Device manufacturer, as written on reports

Depuy Orthopaedics 1818910: medical device reports filed with FDA

43,452 reports name it as the manufacturer of the device involved, 2005–2023.

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.

43,452
reports naming it as manufacturer: 0.2% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 29.3%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

43,452 medical device reports received by FDA give Depuy Orthopaedics 1818910 as the manufacturer of the device involved, 0.2% of the MAUDE database, from May 2005 to April 2023. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

0 reports arrived in the 12 months to August 2026, and none 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 (70.6%), malfunction (29.3%) and death (0.1%). 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 Hip Femoral Head	Prosthesis, hip, semi-constrained, metal/polymer, cemented	842	176	0.7%
Unknown Hip Acetabular Liners	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	819	260	0.2%
Pinnacle Mtl Ins Neut36idx52od	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	814	13	0.1%
Articuleze M Head 36mm +1 5	Prosthesis, hip, semi-constrained, metal/polymer, cemented	706	24	0.1%
Unknown Hip Femoral Stem	Prosthesis, hip, semi-constrained, metal/polymer, cemented	668	79	0.8%
Pinn Straight Cup Impactor	Impactor	646	315	0%
Articuleze M Head 36mm +5	Prosthesis, hip, semi-constrained, metal/polymer, cemented	630	24	0.1%
Pinnacle Mtl Ins Neut36idx54od	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	628	11	0.1%
Excel T-Handle	Orthopedic manual surgical instrument	536	150	0%
Pinnacle Mtl Ins Neut36idx50od	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	432	9	0%
Pinnacle Mtl Ins Neut40idx56od	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	425	6	0.1%
Unknown Hip Acetabular Cup	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	395	106	0.4%
Smartset Gmv 40g Us Eo	Bone cement	381	40	0%
Unknown Knee Tibial Tray	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	372	57	0.2%
Quickset 1pc Flex Drill Bit 25	Bit, drill	369	158	0%
Cor/Tri Ant Stem Insert Shaft	Driver, prosthesis	338	50	0%
Articuleze M Head 36mm +8 5	Prosthesis, hip, semi-constrained, metal/polymer, cemented	304	11	0.1%
Attune Femoral Impactor	Impactor	301	121	0%
Articuleze M Head 36mm -2	Prosthesis, hip, semi-constrained, metal/polymer, cemented	297	10	0.2%
Unknown Knee Tibial Insert	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	297	130	0.2%
Unknown Knee Femoral	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	277	65	0.2%
Unknown Hip Implant	Prosthesis, hip, semi-constrained, metal/polymer, cemented	274	9	0.6%
Sp2 Tibial Radel Impactor	Impactor	263	2	0%
Smartset Ghv Gentamicin 40g	Bone cement	255	40	0.4%
Pinnacle Mtl Ins Neut36idx56od	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	238	5	0.2%
Smartset Mv 40g - Eo	Bone cement	231	4	0.1%
Attune Impaction Handle	Impactor	215	64	0%
Unknown Bone Cement	Bone cement	195	37	0%
Attune Fb Tibial Impactor	Impactor	175	114	0%
Pinnacle Mtl Ins Neut40idx58od	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	167	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
KWA	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	7,418	17.1%
LPH	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	5,938	13.7%
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	5,757	13.2%
JWH	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	5,302	12.2%
LXH	Orthopedic manual surgical instrument	4,438	10.2%
LOD	Bone cement	1,473	3.4%
NJL	Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing	1,425	3.3%
HTO	Reamer	1,364	3.1%
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented	992	2.3%
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	851	2%

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

Death0.1%42

Injury70.6%30,674

Malfunction29.3%12,729

Other0%0

Not given0%7

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

Questions about Depuy Orthopaedics 1818910 reports

How many FDA device reports name Depuy Orthopaedics 1818910 as manufacturer?

43,452 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Unknown Hip Femoral Head (842), Unknown Hip Acetabular Liners (819), Pinnacle Mtl Ins Neut36idx52od (814), Articuleze M Head 36mm +1 5 (706) and Unknown Hip Femoral Stem (668).

Which device types does it report on?

prosthesis, hip, semi-constrained (metal uncemented acetabular component) (17.1%), prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (13.7%), prosthesis, hip, semi-constrained, metal/polymer, cemented (13.2%) and prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (12.2%).

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.