Devices › Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Device brand name · Total hip replacement
Unknown Depuy Head: medical device reports filed with FDA
415 reports name it, 2006–2017. Manufacturer given most often on reports: Depuy Orthopaedics. Product code KWY.
- 415
- device reports naming the brand
- 0% of all MAUDE reports · about 20 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 0.2%
- classified as malfunction
- 7.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
415 medical device reports received by FDA name the brand "Unknown Depuy Head" (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 (99.5%) and malfunction (0.2%); across all prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented reports (product code KWY) death is recorded in 0.3% and malfunction in 7.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device dislodged or dislocated (32%), insufficient device problem information (28%) and implant, removal of (26.3%). The patient problems coded most often are pain, osteolysis and foreign body reaction. 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 Head 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 16,523 reports carrying product code KWY. 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 |
|---|---|---|---|
| Device dislodged or dislocated | 133 | 32% | 15% |
| Insufficient device problem information | 116 | 28% | 23.9% |
| Implant, removal of | 109 | 26.3% | 7.1% |
| Dislocated | 85 | 20.5% | 3.7% |
| Explanted | 24 | 5.8% | 9.7% |
| Metal shedding debris | 15 | 3.6% | 2.1% |
| Replace | 14 | 3.4% | 4.5% |
| Naturally worn | 13 | 3.1% | 5.9% |
| Device remains implanted | 12 | 2.9% | 0.7% |
| Other (for use when an appropriate device code cannot be identified) | 6 | 1.4% | 0.7% |
| Component(s), worn | 5 | 1.2% | 1.6% |
| Loose | 5 | 1.2% | 4% |
| Noise, audible | 5 | 1.2% | 1.4% |
| Fracturea broken bone | 3 | 0.7% | 4.4% |
| Material disintegration | 3 | 0.7% | 0.3% |
| Malposition of device | 2 | 0.5% | 0.7% |
| Corrodedthe device corroded | 1 | 0.2% | 1.5% |
| Device issuea problem with the device | 1 | 0.2% | 0.5% |
| Device slipped | 1 | 0.2% | 1.3% |
| Difficult to position | 1 | 0.2% | 0.1% |
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 |
|---|---|---|
| Painpain, site not specified | 118 | 28.4% |
| Osteolysis | 36 | 8.7% |
| Foreign body reaction | 24 | 5.8% |
| Surgical procedure, repeated | 17 | 4.1% |
| Discomfortdiscomfort | 10 | 2.4% |
| Inflammationinflammation | 10 | 2.4% |
| Joint dislocationa dislocated joint | 9 | 2.2% |
| Falla fall | 6 | 1.4% |
| Foreign body in patientpart of a device left in the patient | 4 | 1% |
| Host-tissue reaction | 4 | 1% |
| Surgical procedure, additional | 4 | 1% |
| Surgical procedure | 3 | 0.7% |
| Ambulation or postural difficulties | 2 | 0.5% |
| Bone fracture(s) | 2 | 0.5% |
| Arthralgiajoint pain | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unknown Depuy Head | Product code KWY | All MAUDE reports |
|---|---|---|---|
| Reports | 415 | 16,523 | 26,136,888 |
| Share of that pool | — | 2.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 99.5% | 90.2% | 36.2% |
| Classified as malfunction | 0.2% | 7.4% | 62.3% |
| Filed by the manufacturer | 100% | 96.2% | 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 KWY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Unknown Hip Femoral Head | 5,080 | 176 | 0.7% |
| Unknown Depuy Femoral Head | 1,559 | 0 | 0.1% |
| Unknown Hip Acetabular Liners | 4,814 | 260 | 0.2% |
| Unknown Hip Femoral Stem | 4,140 | 79 | 0.8% |
| Unknown Depuy Stem | 665 | 0 | 0.3% |
| Unknown Depuy Femoral Stem | 670 | 0 | 0.1% |
| Self Cent Hip 45x28 Gry | 150 | 12 | 0% |
| Unknown Depuy Head Ball | 178 | 0 | 0% |
| Large Mod Head Adapt 12/14 +5 | 750 | 2 | 1.7% |
| Taper Sleeve Adapter 12/14 +2 | 1,025 | 0 | 1.4% |
| Unknown Depuy Asr Sleeve | 301 | 0 | 0.7% |
| Zimmer | 1,159 | 0 | 2.8% |
| Unknown Hip Acetabular Cup | 3,215 | 106 | 0.4% |
| Unknown Hip Femoral Augment | 827 | 0 | 0.4% |
| Bhr | 2,275 | 0 | 0% |
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 Head reports
How many FDA reports name Unknown Depuy Head?
415 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 (99.5%) and malfunction (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device dislodged or dislocated (32%), insufficient device problem information (28%), implant, removal of (26.3%), dislocated (20.5%) and explanted (5.8%). 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 Head 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.