FDA Adverse Event
Malfunction
Summary report: N
NEXGEN COMPLETE KNEE SOLUTION MIS TOTAL KNEE PROCEDURE TIBIAL BROACH IMPACTOR
MDR report key: 1355106
·
Received January 9, 2009
Report
- Report Number
- 1822565-2009-00029
- Event Type
- Malfunction
- Date Received
- January 9, 2009
- Date of Event
- December 2, 2008
- Report Date
- December 2, 2008
- Manufacturer
- ZIMMER, INC.
- Product Code
- HWA
- Removal / Correction Number
- 1822565-2008-002R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION: AS RETURNED, ONE OF THE T-SLOT JAWS HAS FRACTURED. THE DEVICE HAS A POTENTIAL FIELD AGE OF APPROXIMATELY 18 MONTHS. THIS FAILURE WAS CAUSED AS THE STRESS IN THE T-SLOT JAW EXCEEDED MATERIAL LIMITS. MATERIAL WAS ADDED TO THE ROD SHAFT HAW AREA SO THAT A RADIUS TO THE DOVETAIL COULD BE ADDED. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION.
Description of Event or Problem · 1
IT IS REPORTED THAT THE INSTRUMENT BROKE WHILE IMPACTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN COMPLETE KNEE SOLUTION MIS TOTAL KNEE PROCEDURE TIBIAL BROACH IMPACTOR | KNEE INSTRUMENT | HWA | ZIMMER, INC. | NA | 60764371 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |