Devices › Prosthesis, hip, hemi-, acetabular, cemented, metal
Device brand name · Total hip replacement
Unknown Depuy Cup: medical device reports filed with FDA
354 reports name it, 2006–2017. Manufacturer given most often on reports: Depuy Orthopaedics. Product code KWB.
- 354
- device reports naming the brand
- 0% of all MAUDE reports · about 17 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 0.3%
- classified as malfunction
- 6.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
354 medical device reports received by FDA name the brand "Unknown Depuy Cup" (total hip replacement); the manufacturer given most often on reports is Depuy Orthopaedics; received from January 2006 to November 2017. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (99.4%), malfunction (0.3%) and other (0.3%); across all prosthesis, hip, hemi-, acetabular, cemented, metal reports (product code KWB) death is recorded in 0.1% and malfunction in 6.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are implant, removal of (38.7%), loose (19.5%) and loss of osseointegration (13.6%). The patient problems coded most often are osteolysis, pain and surgical procedure, repeated. 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."
Reports by month, five years
No report naming Unknown Depuy Cup was received in the five years to August 2026; the latest was received in November 2017.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 6,783 reports carrying product code KWB. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Implant, removal of | 137 | 38.7% | 32.4% |
| Loose | 69 | 19.5% | 18.2% |
| Loss of osseointegration | 48 | 13.6% | 0.6% |
| Malposition of device | 42 | 11.9% | 1.1% |
| Disassembly | 37 | 10.5% | 1.8% |
| Other (for use when an appropriate device code cannot be identified) | 35 | 9.9% | 3.6% |
| Explanted | 29 | 8.2% | 33.3% |
| Insufficient device problem information | 24 | 6.8% | 4.4% |
| Dislocated | 23 | 6.5% | 12.1% |
| Component(s), worn | 18 | 5.1% | 23.8% |
| Device dislodged or dislocated | 17 | 4.8% | 2.4% |
| Device remains implanted | 15 | 4.2% | 1.9% |
| Replace | 14 | 4% | 15.9% |
| Loose or intermittent connection | 12 | 3.4% | 0.4% |
| Loss of or failure to bond | 10 | 2.8% | 0.3% |
| Metal shedding debris | 6 | 1.7% | 0.4% |
| Fracturea broken bone | 5 | 1.4% | 2.5% |
| Migration or expulsion of device | 5 | 1.4% | 1.1% |
| Naturally worn | 4 | 1.1% | 4% |
| Breakthe device broke | 1 | 0.3% | 2.7% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Osteolysis | 69 | 19.5% |
| Painpain, site not specified | 51 | 14.4% |
| Surgical procedure, repeated | 19 | 5.4% |
| Surgical procedure | 6 | 1.7% |
| Foreign body reaction | 5 | 1.4% |
| Falla fall | 4 | 1.1% |
| Surgical procedure, additional | 4 | 1.1% |
| Joint dislocationa dislocated joint | 3 | 0.8% |
| Arthralgiajoint pain | 2 | 0.6% |
| Bone fracture(s) | 2 | 0.6% |
| Foreign body, removal of | 2 | 0.6% |
| Tissue damage | 2 | 0.6% |
| Host-tissue reaction | 1 | 0.3% |
| Hyperplasia | 1 | 0.3% |
| Impaired healingslow healing | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unknown Depuy Cup | Product code KWB | All MAUDE reports |
|---|---|---|---|
| Reports | 354 | 6,783 | 26,136,888 |
| Share of that pool | — | 5.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 99.4% | 89.3% | 36.2% |
| Classified as malfunction | 0.3% | 6.8% | 62.3% |
| Filed by the manufacturer | 100% | 90.5% | 94.9% |
Shares are of reports, not 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."
Other brands with product code KWB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Unknown Depuy Liner | 1,173 | 0 | 0% |
| Unknown Depuy Hip Liner | 372 | 0 | 0% |
| Unk Depuy Liner | 302 | 0 | 0% |
| Durom Acetabular Component | 2,071 | 0 | 0.1% |
| Reflection | 359 | 0 | 0% |
| Zimmer | 1,159 | 0 | 2.8% |
| Unknown Depuy Duraloc Liner | 264 | 0 | 0% |
| Durom Us Acetabular Component 52/46 L | 285 | 0 | 0% |
| Durom Us Acetabular Component 54/48 N | 288 | 0 | 0% |
| Durom Us Acetabular Component 56/50 P | 234 | 0 | 0% |
| Durom Us Acetabular Component 50/44 J | 222 | 0 | 0% |
| Bhr | 2,275 | 0 | 0% |
| Unknown Depuy Acetabular Cup | 413 | 0 | 0% |
| Durom Us Acetabular Component 58/52 R | 180 | 0 | 0% |
| Biomet | 337 | 0 | 0.3% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Unknown Depuy Cup reports
How many FDA reports name Unknown Depuy Cup?
354 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (99.4%), malfunction (0.3%) and other (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
implant, removal of (38.7%), loose (19.5%), loss of osseointegration (13.6%), malposition of device (11.9%) and disassembly (10.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Unknown Depuy Cup was at fault?
No. 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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.