FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY HIP STEM
MDR report key: 1143607
·
Received August 28, 2008
Report
- Report Number
- 1818910-2008-03462
- Event Type
- Injury
- Date Received
- August 28, 2008
- Date of Event
- July 30, 2008
- Report Date
- July 30, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- KWY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBILE AS THE PRODUCT AND LOT CODE WAS UNAVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION/ERROR REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.
Description of Event or Problem · 1
THE PATIENT WAS REVISED BECAUSE OF OSTEOLYSIS, WEAR AND LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY HIP STEM | TOTAL HIP PROSTHESIS | KWY | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |