FDA Adverse Event
Malfunction
Summary report: N
MOST OPTIONS HINGE KIT
MDR report key: 1021549
·
Received March 27, 2008
Report
- Report Number
- 1822565-2008-00134
- Event Type
- Malfunction
- Date Received
- March 27, 2008
- Date of Event
- February 20, 2008
- Report Date
- February 20, 2008
- Manufacturer
- ZIMMER, INC.
- Product Code
- HRZ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE AXLE IS TOO LARGE FOR THE BUSHINGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MOST OPTIONS HINGE KIT | KNEE PROSTHESIS | HRZ | ZIMMER, INC. | NA | 60812403 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR |