Device manufacturer, as written on reports

Zimmer: medical device reports filed with FDA

47,291 reports name it as the manufacturer of the device involved, 1992–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

47,291
reports naming it as manufacturer: 0.2% of all MAUDE reports; 778
reports, 12 months to August 2026: 929 in the 12 months before; 20.7%
classified as malfunction: 62.3% across all reports; 0.4%
classified as death, as reported: 0.9% across all reports

47,291 medical device reports received by FDA give Zimmer as the manufacturer of the device involved, 0.2% of the MAUDE database, from February 1992 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

778 reports arrived in the 12 months to August 2026, down 16% from 929 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (72.7%), malfunction (20.7%) and other (5.5%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Durom Acetabular Component	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	2,043	0	0.1%
Zimmer	Prosthesis, knee, hemi-, tibial, resurfacing (uncemented)	957	0	2.8%
Unknown Zimmer Knee	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	678	0	0%
Persona Tibial Articular Surface Provisional	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	569	0	0%
Unknown Zimmer Hip	Prosthesis, hip, semi-constrained, metal/polymer, cemented	498	0	0.2%
Nexgen Lps-Flex Femoral Component	Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing	454	0	0%
Unknown Head	Prosthesis, hip, semi-constrained, metal/polymer, cemented	371	103	0.7%
Nexgen Lps-Flex Articular Surface	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	364	0	0%
Durom Hip	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	349	0	0%
Nexgen Lps-Flex Gsf Femoral Component	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	322	0	0%
Durom Acetabular Component 54/48 Code N	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	310	0	0%
Unknown liner	Prosthesis, hip, semi-constrained, metal/polymer, cemented	301	75	0.4%
Durom Acetabular Component 52/46 Code L	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	274	0	0.6%
Durom Us Acetabular Component 52/46 L	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	269	0	0%
Durom Us Acetabular Component 54/48 N	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	264	0	0%
Durom Acetabular Component 56/50 Code P	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	261	0	0.3%
Nexgen Stemmed Tibial Component	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	248	0	0%
Nexgen Cr-Flex Femoral Component	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	231	0	0%
Unknown Stem	Prosthesis, hip, semi-constrained, metal/polymer, cemented	230	84	0.5%
Durom Us Acetabular Component 56/50 P	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	219	0	0%
Durom Acetabular Component 50/44 Code J	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	201	0	0%
Durom Us Acetabular Component 50/44 J	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	188	0	0%
Unknown Cup	Prosthesis, hip, semi-constrained, metal/polymer, cemented	163	66	0.4%
Zimmer M/L Taper Femoral Stem	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	161	0	0%
Durom Acetabular Component 58/52 Code R	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	155	0	0%
Durom Us Acetabular Component 58/52 R	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	144	0	0%
Nexgen Cr-Flex Gsf Femoral Component	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	133	0	0%
Nexgen Mis Stemmed Tibial Component	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	121	0	0%
Nexgen Lps-Flex Prolong Articular Surface	Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer	120	0	0%
Versys Femoral Head	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	108	0	0.3%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product code	Device type	Reports	Share
JWH	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	11,144	23.6%
KWA	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	8,773	18.6%
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	3,619	7.7%
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	2,739	5.8%
LPH	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	2,137	4.5%
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer	1,509	3.2%
KWB	Prosthesis, hip, hemi-, acetabular, cemented, metal	1,221	2.6%
LXH	Orthopedic manual surgical instrument	1,077	2.3%
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented	983	2.1%
HSB	Rod, fixation, intramedullary and accessories	897	1.9%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0.4%183

Injury72.7%34,366

Malfunction20.7%9,768

Other5.5%2,588

Not given0.8%386

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Zimmer reports

How many FDA device reports name Zimmer as manufacturer?

47,291 reports through August 2026, 778 of them in the latest 12 months.

Which of its brands appear most often?

Durom Acetabular Component (2,043), Zimmer (957), Unknown Zimmer Knee (678), Persona Tibial Articular Surface Provisional (569) and Unknown Zimmer Hip (498).

Which device types does it report on?

prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (23.6%), prosthesis, hip, semi-constrained (metal uncemented acetabular component) (18.6%), prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented (7.7%) and prosthesis, hip, semi-constrained, metal/polymer, cemented (5.8%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.