FDA Adverse Event
Injury
Summary report: N
UNKNOWN ZIMMER M/L TAPER STEM
MDR report key: 3022661
·
Received March 22, 2013
Report
- Report Number
- 1822565-2013-00516
- Event Type
- Injury
- Date Received
- March 22, 2013
- Report Date
- February 21, 2013
- Manufacturer
- ZIMMER, INC.
- Product Code
- KWY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PAIN WAS REVISED DUE TO PAIN. DURING THE REVISION, THE SURGEON NOTED TRUNNION CORROSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 119181 | UNKNOWN ZIMMER M/L TAPER STEM | HIP PROSTHESIS | KWY | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |