FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY HIP LINER
MDR report key: 1024377
·
Received April 2, 2008
Report
- Report Number
- 1818910-2008-01144
- Event Type
- Injury
- Date Received
- April 2, 2008
- Date of Event
- March 26, 2008
- Report Date
- March 26, 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
- FL, 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 POSSIBLE 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
PATIENT UNDERWENT SURGERY TO ADDRESS A PATHOLOGIC FRACTURE OF THE GREATER TROCHANTER. POLY WEAR AND OSTEOLYSIS WERE FOUND INTRAOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY HIP LINER | TOTAL HIP PROSTHESIS | KWB | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |