FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY LINER
MDR report key: 1153232
·
Received September 4, 2008
Report
- Report Number
- 1818910-2008-03522
- Event Type
- Injury
- Date Received
- September 4, 2008
- Date of Event
- August 5, 2008
- Report Date
- August 5, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- KWB
- 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
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 STEM AT THE CEMENT/BONE INTERFACE. COMPETITOR'S CEMENT WAS USED AT THE PRIMARY SURGERY. POLY WEAR WAS DISCOVERED INTRAOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY LINER | TOTAL HIP REPLACEMENT | KWB | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Required Intervention |