FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY ASR HIP
MDR report key: 1962326
·
Received January 7, 2011
Report
- Report Number
- 1818910-2010-10695
- Event Type
- Injury
- Date Received
- January 7, 2011
- Report Date
- December 8, 2010
- Manufacturer
- DEPUY INTL., LTD.
- Product Code
- KWA
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
UPDATED INFORMATION RECIEVED BY DEPUY HAS INDICATED THAT THIS REPORT AS AN UNKNOWN HIP SYSTEM IS A DUPLICATE OF:MEDWATCH NUMBER : 1818910-2011-26963, MEDWATCH NUMBER : 1818910-2011-26964, MEDWATCH NUMBER : 1818910-2011-26965,MEDWATCH NUMBER : 1818910-2011-26966,THE COMPLAINT HAS BEEN REJECTED AND NO FURTHER INVESTIGATION WILL BE DONE.
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
RECOMMENDED ASR REVISION - LEFT HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY ASR HIP | 87KWA | KWA | DEPUY INTL., LTD. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |