FDA Adverse Event
Injury
Summary report: N
DEPUY ROT. PLAT. CURVED TIBIAL INSERT
MDR report key: 2113357
·
Received May 27, 2011
Report
- Report Number
- MW5020829
- Event Type
- Injury
- Date Received
- May 27, 2011
- Date of Event
- May 9, 2011
- Report Date
- May 27, 2011
- Manufacturer
- DEPUY ORTHOPAEDICS INC.
- Product Code
- JDI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ACETABULAR FRACTURE NON UNION AND FAILED LEFT TOTAL HIP ARTHROPLASTY. THE ACETABULAR COMPONENT OF THE PROSTHESIS MIGRATED, CAUSING A FAILURE OF THE REPAIR AND NECESSITATING A SECOND OPERATIVE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEPUY ROT. PLAT. CURVED TIBIAL INSERT | HIP PROSTHETIC | JDI | DEPUY ORTHOPAEDICS INC. | 2704858 | ||
| 2 | DEPUY 3-POST ROUND DOME PATELLA | HIP PROSTHETIC | JDI | DEPUY ORTHOPAEDICS INC. | 2837839 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Hospitalization |