Devices › Prosthesis, hip, femoral, resurfacing
Device brand name · Total hip replacement
Unknown Depuy Asr Head: medical device reports filed with FDA
720 reports name it, 2009–2017. Manufacturer given most often on reports: Depuy International. Product code KXA.
- 720
- device reports naming the brand
- 0% of all MAUDE reports · about 41 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 0.3%
- classified as malfunction
- 2.2% across the product code
- 0.4%
- classified as death, as reported
- 3 reports · not verified by FDA
FDA's MAUDE database holds 720 reports that name the brand "Unknown Depuy Asr Head" (total hip replacement), received between January 2009 and June 2017; the manufacturer given most often on reports is Depuy International. Spellings of one product vary from report to report.
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 (99.2%), death (0.4%) and malfunction (0.3%); across all prosthesis, hip, femoral, resurfacing reports (product code KXA) death is recorded in 0.3% and malfunction in 2.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient device problem information (77.5%), metal shedding debris (16.7%) and device dislodged or dislocated (2.2%). The patient problems coded most often are pain, foreign body reaction and discomfort. 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 Asr Head was received in the five years to August 2026; the latest was received in June 2017.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 12,511 reports carrying product code KXA. 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 |
|---|---|---|---|
| Insufficient device problem information | 558 | 77.5% | 60.6% |
| Metal shedding debris | 120 | 16.7% | 6.4% |
| Device dislodged or dislocated | 16 | 2.2% | 4.6% |
| Nonstandard device | 15 | 2.1% | 0.7% |
| Noise, audible | 13 | 1.8% | 4.6% |
| Loss of or failure to bond | 4 | 0.6% | 1.5% |
| Loss of osseointegration | 4 | 0.6% | 5.2% |
| Corrodedthe device corroded | 2 | 0.3% | 1.4% |
| Loosening of implant not related to bone-ingrowth | 1 | 0.1% | 0% |
| Material fragmentation | 1 | 0.1% | 0% |
| Patient-device incompatibilitythe device did not suit the patient | 1 | 0.1% | 0.2% |
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 | 413 | 57.4% |
| Foreign body reaction | 164 | 22.8% |
| Discomfortdiscomfort | 45 | 6.3% |
| Osteolysis | 22 | 3.1% |
| Host-tissue reaction | 18 | 2.5% |
| Joint swellinga swollen joint | 17 | 2.4% |
| Inflammationinflammation | 16 | 2.2% |
| Loss of range of motion | 16 | 2.2% |
| Failure of implant | 15 | 2.1% |
| Synovitis | 14 | 1.9% |
| Foreign body in patientpart of a device left in the patient | 13 | 1.8% |
| Disability | 10 | 1.4% |
| Tissue damage | 9 | 1.3% |
| Limited mobility of the implanted joint | 6 | 0.8% |
| Cyst(s) | 4 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unknown Depuy Asr Head | Product code KXA | All MAUDE reports |
|---|---|---|---|
| Reports | 720 | 12,511 | 26,136,888 |
| Share of that pool | — | 5.8% | 0% |
| Classified as death, per 1,000 reports | 4 | 3 | 9 |
| Classified as injury | 99.2% | 97.3% | 36.2% |
| Classified as malfunction | 0.3% | 2.2% | 62.3% |
| Filed by the manufacturer | 100% | 99% | 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 KXA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Unknown Depuy Asr Femoral Head | 2,339 | 0 | 0.2% |
| Depuy Asr Xl Fem Imp Size 46 | 1,425 | 0 | 0.5% |
| Depuy Asr Xl Fem Imp Size 47 | 1,376 | 4 | 0.5% |
| Depuy Asr Xl Fem Imp Size 49 | 1,241 | 0 | 0.4% |
| Depuy Asr Xl Fem Imp Size 45 | 1,191 | 1 | 0.3% |
| Total Asr Fem Imp Size 51 | 678 | 0 | 0.3% |
| Depuy Asr Xl Fem Imp Size 51 | 865 | 0 | 0.9% |
| Unknown Hip Femoral Stem | 4,140 | 79 | 0.8% |
| Total Asr Fem Imp Size 49 | 631 | 0 | 0% |
| Unknown Hip Femoral Head | 5,080 | 176 | 0.7% |
| Total Asr Fem Imp Size 47 | 569 | 0 | 0% |
| Total Asr Fem Imp Size 46 | 534 | 0 | 0% |
| Total Asr Fem Imp Size 53 | 449 | 0 | 0% |
| Total Asr Fem Imp Size 45 | 442 | 0 | 0% |
| Depuy Asr Xl Fem Imp Size 43 | 626 | 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 Asr Head reports
How many FDA reports name Unknown Depuy Asr Head?
720 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 (99.2%), death (0.4%) and malfunction (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (77.5%), metal shedding debris (16.7%), device dislodged or dislocated (2.2%), nonstandard device (2.1%) and noise, audible (1.8%). 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 Asr 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.