Device manufacturer, as written on reports

Depuy Orthopaedics: medical device reports filed with FDA

54,656 reports name it as the manufacturer of the device involved, 1996–2026.

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.

54,656
reports naming it as manufacturer: 0.2% of all MAUDE reports; 124
reports, 12 months to August 2026: 111 in the 12 months before; 22%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

54,656 medical device reports received by FDA give Depuy Orthopaedics as the manufacturer of the device involved, 0.2% of the MAUDE database, from September 1996 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

124 reports arrived in the 12 months to August 2026, up 12% from 111 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 (77.6%), malfunction (22%) and other (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 Depuy Liner	Prosthesis, hip, hemi-, acetabular, cemented, metal	836	0	0%
Attune Femoral Impactor	Impactor	543	121	0%
Unknown Depuy Insert	Prosthesis, knee, hemi-, tibial, resurfacing (uncemented)	481	0	0%
Pinn Straight Cup Impactor	Impactor	382	315	0%
Unknown Depuy Tibial Tray	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	372	0	0%
Unknown Depuy Tibial Insert	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	363	0	0%
Unknown Depuy Patella	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	359	0	0%
Attune Fb Tibial Impactor	Impactor	326	114	0%
Attune Impaction Handle	Impactor	308	64	0%
Excel T-Handle	Orthopedic manual surgical instrument	305	150	0%
Unknown Depuy Femoral Component	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	293	0	0%
Unknown Depuy Stem	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented	292	0	0.3%
Unk Depuy Liner	Prosthesis, hip, hemi-, acetabular, cemented, metal	289	0	0%
Unknown Depuy Femoral Stem	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	283	0	0.1%
Unknown Depuy Hip Liner	Prosthesis, hip, hemi-, acetabular, cemented, metal	283	0	0%
Quickset 1pc Flex Drill Bit 25	Bit, drill	275	158	0%
Cor/Tri Ant Stem Insert Shaft	Driver, prosthesis	270	50	0%
Unknown Depuy Cup	Prosthesis, hip, hemi-, acetabular, cemented, metal	240	0	0%
Unknown Depuy Femoral Head	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented	235	0	0.1%
Unknown Depuy Head	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented	200	0	0%
Sp2 Tibial Radel Impactor	Impactor	196	2	0%
Angled Acet Insertr	Driver, prosthesis	188	59	0%
Unk Depuy Insert	Prosthesis, knee, hemi-, tibial, resurfacing (uncemented)	184	0	0%
Attune Spacer Block	Template	150	80	0%
Unknown Depuy Acetabular Cup	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	140	0	0%
Unknown Depuy Head Ball	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented	135	0	0%
Unknown Depuy Acetabular Liner	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	123	0	0%
Quickset 1pc Flex Drill Bit 30	Bit, drill	122	49	0%
Duraloc Str Cup Impactor	Impactor	115	57	0%
Quickset 1pc Flex Drill Bit 35	Bit, drill	113	38	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	9,143	16.7%
JWH	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	7,221	13.2%
LXH	Orthopedic manual surgical instrument	6,544	12%
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	5,128	9.4%
KWA	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	4,229	7.7%
KWB	Prosthesis, hip, hemi-, acetabular, cemented, metal	2,900	5.3%
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented	2,580	4.7%
NJL	Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing	2,005	3.7%
HSH	Prosthesis, knee, hemi-, tibial, resurfacing (uncemented)	1,867	3.4%
HRY	Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer	1,169	2.1%

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%37

Injury77.6%42,427

Malfunction22%12,037

Other0.1%61

Not given0.2%94

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 reports

How many FDA device reports name Depuy Orthopaedics as manufacturer?

54,656 reports through August 2026, 124 of them in the latest 12 months.

Which of its brands appear most often?

Unknown Depuy Liner (836), Attune Femoral Impactor (543), Unknown Depuy Insert (481), Pinn Straight Cup Impactor (382) and Unknown Depuy Tibial Tray (372).

Which device types does it report on?

prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (16.7%), prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (13.2%), orthopedic manual surgical instrument (12%) and prosthesis, hip, semi-constrained, metal/polymer, cemented (9.4%).

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.