FDA Adverse Event
Injury
Summary report: N
ASR ACETABULAR CUPS 48
MDR report key: 1954300
·
Received January 5, 2011
Report
- Report Number
- 1818910-2011-00040
- Event Type
- Injury
- Date Received
- January 5, 2011
- Date of Event
- December 6, 2010
- Report Date
- December 6, 2010
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- KWA
- PMA / PMN Number
- K040627
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
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
PT WAS REVISED TO ADDRESS LOOSENING OF THE ASR CUP, HIGH COBALT LEVELS, AND PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASR ACETABULAR CUPS 48 | 87KWA | KWA | DEPUY INTERNATIONAL, LTD. | NA | 2664871 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |