FDA Adverse Event
Injury
Summary report: N
UNKNOWN ZIMMER HIP STEM
MDR report key: 1081770
·
Received July 25, 2008
Report
- Report Number
- 1822565-2008-00447
- Event Type
- Injury
- Date Received
- July 25, 2008
- Date of Event
- September 20, 2005
- Report Date
- June 26, 2008
- Manufacturer
- ZIMMER, INC.
- Product Code
- KWY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
WE COULD NOT OBTAIN A COMPLETE CATALOG NUMBER; THEREFORE, A BASELINE REPORT CANNOT BE FILED. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 1999. TWO-THREE YRS LATER, PT STARTED EXPERIENCING LEG PAIN AND TURNING OF FOOT UPON WALKING. PT STARTED USING A CANE TO ASSIST WALKING, DUE TO PAIN AND CONTROL. PT HAD REVISION SURGERY PERFORMED IN 2005.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN ZIMMER HIP STEM | HIP PROSTHESIS | KWY | ZIMMER, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| R |