Device manufacturer, as written on reports

Depuy Orthopaedics US: medical device reports filed with FDA

149,624 reports name it as the manufacturer of the device involved, 2006–2026.

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.

149,624
reports naming it as manufacturer: 0.6% of all MAUDE reports; 12,085
reports, 12 months to August 2026: 12,131 in the 12 months before; 38.6%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

149,624 medical device reports received by FDA give Depuy Orthopaedics US as the manufacturer of the device involved, 0.6% of the MAUDE database, from August 2006 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

12,085 reports arrived in the 12 months to August 2026, close to the 12,131 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 (61.2%), malfunction (38.6%) and death (0.2%). 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 Acetabular Liners	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	3,636	260	0.2%
Pinn Straight Cup Impactor	Impactor	3,583	315	0%
Unknown Hip Femoral Head	Prosthesis, hip, semi-constrained, metal/polymer, cemented	3,334	176	0.7%
Unknown Hip Femoral Stem	Prosthesis, hip, semi-constrained, metal/polymer, cemented	3,147	79	0.8%
Unknown Hip Acetabular Cup	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	2,011	106	0.4%
Unknown Knee Tibial Insert	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	1,769	130	0.2%
Pinnacle Mtl Ins Neut36idx52od	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	1,670	13	0.1%
Quickset 1pc Flex Drill Bit 25	Bit, drill	1,563	158	0%
Excel T-Handle	Orthopedic manual surgical instrument	1,410	150	0%
Articuleze M Head 36mm +1 5	Prosthesis, hip, semi-constrained, metal/polymer, cemented	1,388	24	0.1%
Pinnacle Mtl Ins Neut36idx54od	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	1,289	11	0.1%
Unknown Knee Femoral	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	1,265	65	0.2%
Articuleze M Head 36mm +5	Prosthesis, hip, semi-constrained, metal/polymer, cemented	1,224	24	0.1%
Unknown Knee Tibial Tray	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	1,073	57	0.2%
Quickset Ace Grater Head 51mm	Reamer	934	11	0%
Quickset Ace Grater Head 49mm	Reamer	903	13	0%
Quickset Ace Grater Head 53mm	Reamer	899	10	0%
Quickset Ace Grater Head 55mm	Reamer	831	10	0%
Quickset Ace Grater Head 47mm	Reamer	821	13	0%
Quickset Ace Grater Head 57mm	Reamer	808	9	0%
Pinnacle Mtl Ins Neut36idx50od	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	790	9	0%
Pinnacle Mtl Ins Neut40idx56od	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	762	6	0.1%
UNK Hip Femoral Head Ceramic	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	706	126	0.1%
Quickset Ace Grater Head 45mm	Reamer	699	13	0%
Unk Reamer	Reamer	670	71	0%
Quickset Ace Grater Head 48mm	Reamer	644	9	0%
Quickset Ace Grater Head 52mm	Reamer	638	10	0%
Quickset Ace Grater Head 54mm	Reamer	628	10	0%
Articuleze M Head 36mm +8 5	Prosthesis, hip, semi-constrained, metal/polymer, cemented	617	11	0.1%
Quickset Ace Grater Head 50mm	Reamer	613	10	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
LPH	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	27,157	18.2%
HTO	Reamer	19,485	13%
JWH	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	15,884	10.6%
KWA	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	15,462	10.3%
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	13,161	8.8%
NJL	Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing	5,745	3.8%
HWA	Impactor	5,390	3.6%
HWT	Template	5,051	3.4%
LXH	Orthopedic manual surgical instrument	4,806	3.2%
HTW	Bit, drill	4,486	3%

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

Death0.2%235

Injury61.2%91,603

Malfunction38.6%57,784

Other0%0

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 Depuy Orthopaedics US reports

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

149,624 reports through August 2026, 12,085 of them in the latest 12 months.

Which of its brands appear most often?

Unknown Hip Acetabular Liners (3,636), Pinn Straight Cup Impactor (3,583), Unknown Hip Femoral Head (3,334), Unknown Hip Femoral Stem (3,147) and Unknown Hip Acetabular Cup (2,011).

Which device types does it report on?

prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (18.2%), reamer (13%), prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (10.6%) and prosthesis, hip, semi-constrained (metal uncemented acetabular component) (10.3%).

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.