FDA Adverse Event
Malfunction
Summary report: N
NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED PROLONG HIGHLY CR
MDR report key: 1150090
·
Received August 29, 2008
Report
- Report Number
- 1822565-2008-00568
- Event Type
- Malfunction
- Date Received
- August 29, 2008
- Date of Event
- July 23, 2008
- Report Date
- August 12, 2008
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: A REVIEW OF THE MANUFACTURING RECORDS INDICATE THAT THE SCREW INSERT KIT WAS ISSUED TO THE ORDER AND WAS PACKAGED ACCORDING TO SPECIFICATION. THE RELATED MANUFACTURING LOT WAS FULLY DISTRIBUTED WITHOUT ANY FURTHER REPORTS OF THE KIND. IT CAN NOT BE DETERMINED WITH CERTAINTY THE CAUSE OF THE REPORT, BUT IT IS POSSIBLE THAT THE SCREW MAY HAVE BEEN DISCARDED AFTER BEING DISTRIBUTED. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: DEVICE HISTORY RECORDS INDICATE DEVICE MANUFACTURED TO SPECIFICATION.
Description of Event or Problem · 1
IT IS REPORTED THAT DURING SURGERY IN 2008, THE HOSPITAL OPENED THE PACKAGE AND CLAIMS THAT THE METAL PLATE AND SCREW WERE NOT PACKAGED WITH THE SURFACE. IMPLANT WAS OPENED ON BACK TABLE BY HOSPITALS SURGERY TECH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED PROLONG HIGHLY CR | KNEE PROSTHESIS | JWH | ZIMMER, INC. | NA | 60655789 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |