FDA Adverse Event
Injury
Summary report: N
UNKNOWN ZIMMER HIP
MDR report key: 1930692
·
Received December 14, 2010
Report
- Report Number
- 1822565-2010-01348
- Event Type
- Injury
- Date Received
- December 14, 2010
- Date of Event
- October 21, 2009
- Report Date
- November 17, 2010
- Manufacturer
- ZIMMER, INC.
- Product Code
- JDG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
INFO WAS RECEIVED FROM A CONSUMER 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 REPORTING THAT THE PT WAS REVISED DUE TO PAIN AND LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN ZIMMER HIP | HIP PROSTHESIS | JDG | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |