FDA Adverse Event
Injury
Summary report: N
ASR ACETABULAR CUPS 54
MDR report key: 1061380
·
Received June 13, 2008
Report
- Report Number
- 1818910-2008-02571
- Event Type
- Injury
- Date Received
- June 13, 2008
- Report Date
- May 15, 2008
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- KWA
- PMA / PMN Number
- K040627
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EXAMINATION IS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. REVIEW OF PROVIDED PT X-RAYS IS UNABLE TO CONCLUSIVELY DETERMINE A ROOT CAUSE FOR THE REPORT. A COMPLAINT'S DATABASE SEARCHES MADE ON PRODUCT LOT 2297152 IDENTIFIED NO SIMILAR COMPLAINTS RECEIVED PREVIOUSLY. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. MONITOR THROUGH TREND ANALYSIS.
Description of Event or Problem · 1
THE PT WAS REVISED BECAUSE OF LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASR ACETABULAR CUPS 54 | 87KWA | KWA | DEPUY INTERNATIONAL, LTD. | NA | 2297152 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |