FDA Adverse Event
Injury
Summary report: N
ZIMMER M/L TAPER HIP PROSTHESIS FEMORAL STEM PRESS-FIT PLASMA SPRAYED NECK TAPER
MDR report key: 1060441
·
Received June 13, 2008
Report
- Report Number
- 1822565-2008-00319
- Event Type
- Injury
- Date Received
- June 13, 2008
- Date of Event
- September 24, 2007
- Report Date
- May 14, 2008
- Manufacturer
- ZIMMER, INC.
- Product Code
- KWY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CAUSE CANNOT BE DEFINITIVELY DETERMINED. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.
Description of Event or Problem · 1
IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2007. THE DEVICE WAS REVISED THE FOLLOWING MONTH, DUE TO LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER M/L TAPER HIP PROSTHESIS FEMORAL STEM PRESS-FIT PLASMA SPRAYED NECK TAPER | HIP PROSTHESIS | KWY | ZIMMER, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |