FDA Adverse Event
Malfunction
Summary report: N
NEXGEN MIS STEMMED TIBIAL COMPONENT
MDR report key: 2516452
·
Received March 30, 2012
Report
- Report Number
- 2648920-2012-00076
- Event Type
- Malfunction
- Date Received
- March 30, 2012
- Date of Event
- March 2, 2012
- Report Date
- March 2, 2012
- Manufacturer
- ZIMMER MANUFACTURING B.V.
- Product Code
- JWH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ONLY THE FRACTURED PORTION OF THE TIBIAL COMPONENT WAS RETURNED FOR EVAL. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT WHILE THE SURGEON WAS INSERTING THE TIBIAL BASEPLATE A PORTION OF THE DEVICE FRACTURED OFF. THE SURGEON DECIDED TO LEAVE THE BASEPLATE IMPLANTED BUT IS CONCERNED THAT THE BROKEN PLATE MIGHT CAUSE THE PROBLEM TO THE PT IN THE FUTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN MIS STEMMED TIBIAL COMPONENT | JWH | ZIMMER MANUFACTURING B.V. | 61958856 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |