FDA Adverse Event
Injury
Summary report: N
ZIMMER FEMORAL HEAD 6 DEGREE TAPER
MDR report key: 623539
·
Received July 29, 2005
Report
- Report Number
- 2648920-2005-00019
- Event Type
- Injury
- Date Received
- July 29, 2005
- Date of Event
- June 10, 2005
- Report Date
- June 30, 2005
- Manufacturer
- ZIMMER CARIBE
- Product Code
- JDI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT IS REPORTED THAT PT UNDERWENT THA IN 01/2003. DEVICES DISLOCATED IN JUNE 2005. X-RAY WAS TAKEN IN 06/2005 WHICH SHOWED THE STEM AND HEAD HAD SEPARATED. DEVICES WERE REVISED IN 06/2005.
Description of Event or Problem · 1
PATIENT UNDERWENT THA IN 2003. DEVICES DISLOCATED IN JUNE 2005. X-RAY WAS TAKEN IN 2005 WHICH SHOWED THE STEM AND HEAD HAD SEPARATED. DEVICES WERE REVISED ON THE 2ND DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER FEMORAL HEAD 6 DEGREE TAPER | HIP PROSTHESIS | JDI | ZIMMER CARIBE | NA | 25738000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Hospitalization| R |