FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN ZIMMER ARTICULAR SURFACE
MDR report key: 874876
·
Received July 3, 2007
Report
- Report Number
- 1822565-2007-00231
- Event Type
- Malfunction
- Date Received
- July 3, 2007
- Report Date
- June 12, 2007
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WE COULD NOT OBTAIN A COMPLETE CATALOG NUMBER, THEREFORE, A BASELINE REPORT CANNOT BE FILED. EVAL SUMMARY: CAUSE OF THE PROBLEM COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFO. EVAL: NO PRODUCT WAS RETURNED FOR REVIEW. NO LOT NUMBER WAS PROVIDED; THEREFORE, MFG RECORDS COULD NOT BE REVIEWED.
Description of Event or Problem · 1
IT IS REPORTED THAT THE SURGEON IMPLANTED THE INCORRECT SIZE ARTICULATING SURFACE. A "STRIPED GREEN G/H" WAS IMPLANTED INSTEAD OF A "STRIPED GREEN C/D".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN ZIMMER ARTICULAR SURFACE | KNEE PROSTHESIS | JWH | ZIMMER, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |