FDA Adverse Event
Injury
Summary report: N
ZIMMER INC CUP 58MM/50MM CODE P
MDR report key: 4012853
·
Received July 31, 2014
Report
- Report Number
- 9613350-2014-03757
- Event Type
- Injury
- Date Received
- July 31, 2014
- Date of Event
- April 23, 2014
- Report Date
- July 7, 2014
- Manufacturer
- ZIMMER GMBH
- Product Code
- JDI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. ONCE MORE DETAILED INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED. (B)(4).
Description of Event or Problem · 1
A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A ZIMMER MMC CUP 58MM/50MM CODE P ON (B)(6) 2012 ON THE RIGHT SIDE. THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO PAIN AND LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 447197 | ZIMMER INC CUP 58MM/50MM CODE P | ZIMMER MMC CUP | JDI | ZIMMER GMBH | 2528481 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |