FDA Adverse Event
Malfunction
Summary report: N
NEXGEN LPS PROVISIOAL ARTICULAR SURFACE
MDR report key: 2151352
·
Received June 21, 2011
Report
- Report Number
- 1822565-2011-01471
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- May 16, 2011
- Report Date
- May 27, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVAL SUMMARY: WHILE A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED FAILURES OF THIS TYPE, AT THE MOLD WELD LINE, CAN BE DUE TO REPEATED USE AND AUTOCLAVING. DUE TO THE AGE OF THE DEVICE, THE PRODUCT EXCEEDED ITS USEFUL LIFE, DUE TO NORMAL WEAR. EVAL: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MFG AND INSPECTED TO SPECIFICATION. NO MFG ABNORMALITIES COULD BE DETECTED BY EITHER METHOD.
Description of Event or Problem · 1
IT IS REPORTED THAT THE POLY BROKE IN HALF DURING REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN LPS PROVISIOAL ARTICULAR SURFACE | JWH | ZIMMER, INC. | 63318100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |