FDA Adverse Event
Injury
Summary report: N
UNKNOWN ZIMMER ZMR HIP STEM
MDR report key: 1940539
·
Received December 21, 2010
Report
- Report Number
- 1822565-2010-01435
- Event Type
- Injury
- Date Received
- December 21, 2010
- Date of Event
- November 23, 2010
- Report Date
- November 23, 2010
- Manufacturer
- ZIMMER, INC.
- Product Code
- KWY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INFO WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT DURING A REVISION FOR INFECTION, THE SURGEON WAS UNABLE TO GET THE STEM AND BODY SEPARATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN ZIMMER ZMR HIP STEM | HIP PROSTHESIS | KWY | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | UNK ZIMMER ZMR HIP BODY, LOT: UNK, CATALOG: UNK |