FDA Adverse Event
Injury
Summary report: N
ZIMMER ANATOMIC II HIP PROSTHESIS FEMORAL STEM
MDR report key: 732252
·
Received July 5, 2006
Report
- Report Number
- 1822565-2006-00157
- Event Type
- Injury
- Date Received
- July 5, 2006
- Report Date
- May 10, 2006
- Manufacturer
- ZIMMER, INC.
- Product Code
- JDG
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: PROBABLE CAUSE IS UNK. DEVICE AND X-RAYS WERE NOT RETURNED FOR REVIEW. NO CATALOG NUMBER OR LOT NUMBER WAS PROVIDED; THEREFORE, MANUFACTURING RECORDS COULD NOT BE REVIEWED.
Description of Event or Problem · 1
IT IS RPEORTED THAT THE DEVICE WAS IMPLANTED IN 2004. THE LENGTH OF THE LEG WAS INCREASED TOO MUCH. THE PT'S FEMUR FRACTURED AND REVISION WAS REQ. EXPLANT DATE IS UNK
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER ANATOMIC II HIP PROSTHESIS FEMORAL STEM | HIP PROSTHESIS | JDG | ZIMMER, INC. | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| R |