Device manufacturer, as written on reports

Depuy Warsaw: medical device reports filed with FDA

7,534 reports name it as the manufacturer of the device involved, 2011–2013.

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.

7,534
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 2.2%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

7,534 medical device reports received by FDA give Depuy Warsaw as the manufacturer of the device involved, 0% of the MAUDE database, from April 2011 to May 2013. 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 (97.7%), malfunction (2.2%) 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 Depuy Liner	Prosthesis, hip, hemi-, acetabular, cemented, metal	154	0	0%
Unknown Depuy Poly Liner	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	105	0	0%
Unknown Depuy Tibial Insert	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	104	0	0%
Unknown Depuy Head	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented	96	0	0%
Unknown Depuy Femoral Head	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented	82	0	0.1%
Unknown Depuy Duraloc Liner	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	67	0	0%
Unknown Depuy Stem	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented	62	0	0.3%
Unknown Depuy Tibial Tray	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	58	0	0%
Unknown Depuy Cup	Prosthesis, hip, hemi-, acetabular, cemented, metal	46	0	0%
Unknown Depuy Patella	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	46	0	0%
Unknown Depuy Acetabular Liner	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	42	0	0%
Unknown Depuy Femoral Component	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	36	0	0%
Altrx +4 10d 36idx52od	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	33	17	0.2%
Unknown Depuy Hip Liner	Prosthesis, hip, hemi-, acetabular, cemented, metal	31	0	0%
Altrx +4 10d 32idx50od	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	26	13	0%
Mbt Cem Keel Tib Tray Sz3	Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing	25	9	0%
Unknown Depuy Cement	Bone cement	18	0	0.3%
Enduron 10d 56 Or 68odx28id	Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer	17	2	0%
Pinn Sector W/Gription 50mm	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	17	10	0%
Altrx +4 Neut 36idx52od	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	16	17	0%
Enduron 10d 54od X 28id	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	16	0	0%
Unknown Depuy Head Ball	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented	16	0	0%
Altrx +4 Neut 32idx50od	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	15	6	0%
Altrx +4 Neut 36idx54od	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	15	15	0%
Unknown Depuy Femoral Stem	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	12	0	0.1%
Enduron 10d 52od X 28id	Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer	10	0	0%
Altrx +4 10d 36idx54od	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	9	8	0%
Altrx +4 10d 40idx56od	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	7	4	0%
Articul/Eze Ball 28 +1 5 Gr	Prosthesis, hip, semi-constrained, metal/polymer, cemented	7	20	0.3%
Pinn Mar +4 10d 32idx50od	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	7	3	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	2,078	27.6%
JWH	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	1,414	18.8%
KWA	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	977	13%
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	955	12.7%
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented	471	6.3%
NJL	Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing	413	5.5%
LXH	Orthopedic manual surgical instrument	138	1.8%
HWC	Screw, fixation, bone	75	1%
KWS	Prosthesis, shoulder, semi-constrained, metal/polymer cemented	69	0.9%
HRY	Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer	46	0.6%

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%6

Injury97.7%7,362

Malfunction2.2%164

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 Warsaw reports

How many FDA device reports name Depuy Warsaw as manufacturer?

7,534 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Unknown Depuy Liner (154), Unknown Depuy Poly Liner (105), Unknown Depuy Tibial Insert (104), Unknown Depuy Head (96) and Unknown Depuy Femoral Head (82).

Which device types does it report on?

prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (27.6%), prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (18.8%), prosthesis, hip, semi-constrained (metal uncemented acetabular component) (13%) and prosthesis, hip, semi-constrained, metal/polymer, cemented (12.7%).

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.