FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY ASR FEMORAL HEAD
MDR report key: 2800197
·
Received October 22, 2012
Report
- Report Number
- 1818910-2012-26308
- Event Type
- Injury
- Date Received
- October 22, 2012
- Date of Event
- October 9, 2012
- Report Date
- February 27, 2026
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- KWA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
PATIENT WAS REVISED DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY ASR FEMORAL HEAD | FEMORAL HEAD | KWA | DEPUY INTERNATIONAL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention |