Device manufacturer, as written on reports

Zimmer Biomet: medical device reports filed with FDA

83,997 reports name it as the manufacturer of the device involved, 2012–2026.

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.

83,997
reports naming it as manufacturer: 0.3% of all MAUDE reports; 8,846
reports, 12 months to August 2026: 8,236 in the 12 months before; 33.7%
classified as malfunction: 62.3% across all reports; 0.4%
classified as death, as reported: 0.9% across all reports

83,997 medical device reports received by FDA give Zimmer Biomet as the manufacturer of the device involved, 0.3% of the MAUDE database, from January 2012 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

8,846 reports arrived in the 12 months to August 2026, close to the 8,236 of 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 (65.9%), malfunction (33.7%) and death (0.4%). 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
Unknown Head	Prosthesis, hip, semi-constrained, metal/polymer, cemented	1,548	103	0.7%
Unknown liner	Prosthesis, hip, semi-constrained, metal/polymer, cemented	1,469	75	0.4%
Unknown Stem	Prosthesis, hip, semi-constrained, metal/polymer, cemented	1,158	84	0.5%
Unknown Cup	Prosthesis, hip, semi-constrained, metal/polymer, cemented	1,020	66	0.4%
Persona Tibial Articular Surface Provisional	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	959	0	0%
Unknown Screw	Screw, fixation, bone	579	156	0%
Disposable Mixing Bowl And Spatula	Mixer, cement, for clinical use	480	210	0%
Unknown Femoral Component	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	453	90	0.3%
Juggerstitch Curved Implant	Fastener, fixation, nondegradable, soft tissue	417	46	0%
Unknown Articular Surface	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	414	78	0%
Taperloc Complete	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	392	319	0%
Unk head	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	367	146	0.5%
Tibial Articular Surface Provisional Left Size Ef	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	359	0	0%
Tibial Articular Surface Provisional Right Size Ef	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	356	0	0%
Femoral Cr Impactor Pad	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	334	12	0%
Unk Liner	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	304	121	0%
Compr Metal Impactor	Prosthesis, shoulder, semi-constrained, metal/polymer cemented	302	37	0%
Unknown Knee	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	302	18	1.5%
Unknown Hip	Prosthesis, hip, semi-constrained, metal/polymer, cemented	288	5	1.9%
Persona FEMORAL CR IMPACTOR PAD	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	247	33	0%
Tibial Articular Surface Provisional Left Size Gh	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	221	0	0%
Unk Stem	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	216	101	0.7%
Tibial Articular Surface Provisional Right Size Cd	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	211	0	0%
Tibial Articular Surface Provisional Left Size Cd	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	208	0	0%
Persona Tibial Articular Surface Provisional Shim	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	203	14	0%
Unknown Tibial Tray	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	186	25	0.2%
Unknown Bearing	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	185	84	0.3%
UNK Cup	Prosthesis, hip, semi-constrained, metal/polymer, cemented	179	78	0%
Tibial Articular Surface Provisional Right Size Gh	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	178	0	0%
Tear Drop Guide Wire 3 0 Mm Diameter 100 Cm Length	Rod, fixation, intramedullary and accessories	173	0	0%

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	24,295	28.9%
LPH	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	10,033	11.9%
KWA	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	7,368	8.8%
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	7,017	8.4%
KWS	Prosthesis, shoulder, semi-constrained, metal/polymer cemented	3,225	3.8%
MBH	Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer	2,965	3.5%
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	2,836	3.4%
PHX	Shoulder prosthesis, reverse configuration	2,466	2.9%
LXH	Orthopedic manual surgical instrument	2,357	2.8%
PBI	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive	1,434	1.7%

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%354

Injury65.9%55,333

Malfunction33.7%28,305

Other0%3

Not given0%2

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

Questions about Zimmer Biomet reports

How many FDA device reports name Zimmer Biomet as manufacturer?

83,997 reports through August 2026, 8,846 of them in the latest 12 months.

Which of its brands appear most often?

Unknown Head (1,548), Unknown liner (1,469), Unknown Stem (1,158), Unknown Cup (1,020) and Persona Tibial Articular Surface Provisional (959).

Which device types does it report on?

prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (28.9%), prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (11.9%), prosthesis, hip, semi-constrained (metal uncemented acetabular component) (8.8%) and prosthesis, hip, semi-constrained, metal/polymer, cemented (8.4%).

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.