FDA Adverse Event
Malfunction
Summary report: N
NEXGEN COMPLETE KNEE SOLUTION POSTERIOR FEMORAL AUGMENT BLOCK
MDR report key: 1031695
·
Received April 18, 2008
Report
- Report Number
- 1822565-2008-00187
- Event Type
- Malfunction
- Date Received
- April 18, 2008
- Date of Event
- March 7, 2008
- Report Date
- March 12, 2008
- Manufacturer
- ZIMMER, INC.
- Product Code
- HSA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION SUMMARY: THE INNER CAVITY PEEL TAB WAS NOT FOLDED DOWN AND WAS NOT SEALED INTO OUTER CAVITY FLANGE AREA. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: DEVICE HISTORY RECORDS INDICATE DEVICE MANUFACTURED TO SPECIFICATION.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PACKAGING STUCK TOGETHER, AND WAS, THEREFORE, HARD TO OPEN CAUSING THE IMPLANT TO FALL OUT ONTO THE FLOOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN COMPLETE KNEE SOLUTION POSTERIOR FEMORAL AUGMENT BLOCK | KNEE PROSTHESIS | HSA | ZIMMER, INC. | NA | 78233000V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |