Devices › Prosthesis, hip, femoral, resurfacing
Device brand name · Hip femoral head
Unidentified Asr Head: medical device reports filed with FDA
211 reports name it, 2013–2017. Manufacturer given most often on reports: Depuy Intl - 8010379. Product code KXA.
- 211
- device reports naming the brand
- 0% of all MAUDE reports · about 16 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 0%
- classified as malfunction
- 2.2% across the product code
- 2.4%
- classified as death, as reported
- 5 reports · not verified by FDA
FDA's MAUDE database holds 211 reports that name the brand "Unidentified Asr Head" (hip femoral head), received between April 2013 and April 2017; the manufacturer given most often on reports is Depuy Intl - 8010379. 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 (97.6%) and death (2.4%); 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 (82.9%), device dislodged or dislocated (2.4%) and nonstandard device (2.4%). The patient problems coded most often are pain, host-tissue reaction 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 Unidentified Asr Head was received in the five years to August 2026; the latest was received in April 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 | 175 | 82.9% | 60.6% |
| Device dislodged or dislocated | 5 | 2.4% | 4.6% |
| Nonstandard device | 5 | 2.4% | 0.7% |
| Loss of osseointegration | 4 | 1.9% | 5.2% |
| Metal shedding debris | 3 | 1.4% | 6.4% |
| Corrodedthe device corroded | 2 | 0.9% | 1.4% |
| Noise, audible | 2 | 0.9% | 4.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 1 | 0.5% | 0.2% |
| Migration or expulsion of device | 1 | 0.5% | 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 | 56 | 26.5% |
| Host-tissue reaction | 15 | 7.1% |
| Foreign body reaction | 9 | 4.3% |
| Ambulation or postural difficulties | 4 | 1.9% |
| Bone fracture(s) | 4 | 1.9% |
| Deaththe patient died; cause not stated by this term | 4 | 1.9% |
| Limited mobility of the implanted joint | 3 | 1.4% |
| Osteolysis | 3 | 1.4% |
| Discomfortdiscomfort | 2 | 0.9% |
| Falla fall | 2 | 0.9% |
| Loss of range of motion | 2 | 0.9% |
| Toxicity | 2 | 0.9% |
| Cyst(s) | 1 | 0.5% |
| Hair loss | 1 | 0.5% |
| Inflammationinflammation | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unidentified Asr Head | Product code KXA | All MAUDE reports |
|---|---|---|---|
| Reports | 211 | 12,511 | 26,136,888 |
| Share of that pool | — | 1.7% | 0% |
| Classified as death, per 1,000 reports | 24 | 3 | 9 |
| Classified as injury | 97.6% | 97.3% | 36.2% |
| Classified as malfunction | 0% | 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% |
| Unknown Depuy Asr Head | 720 | 0 | 0.4% |
| 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% |
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 Unidentified Asr Head reports
How many FDA reports name Unidentified Asr Head?
211 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 (97.6%) and death (2.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (82.9%), device dislodged or dislocated (2.4%), nonstandard device (2.4%), loss of osseointegration (1.9%) and metal shedding debris (1.4%). 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 Unidentified 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.