FDA Adverse Event
Injury
Summary report: N
DEPUY ASR XL FEM IMP SIZE 45
MDR report key: 2211696
·
Received August 10, 2011
Report
- Report Number
- 1818910-2011-13490
- Event Type
- Injury
- Date Received
- August 10, 2011
- Report Date
- July 12, 2011
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- KWA
- PMA / PMN Number
- NA
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
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. NO 510K# SUBMITTED AS DEPUY ORTHOPAEDICS SELLS A SIMILAR PRODUCT (OR THE SAME PRODUCT WITH A DIFFERENT PRODUCT CODE) IN THE U.S.
Description of Event or Problem · 1
ASR REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEPUY ASR XL FEM IMP SIZE 45 | 87KWA | KWA | DEPUY INTERNATIONAL, LTD. | NA | 2677928 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |