FDA Adverse Event
Injury
Summary report: N
NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE TIBIAL COMPONENT
MDR report key: 865914
·
Received June 13, 2007
Report
- Report Number
- 1822565-2007-00181
- Event Type
- Injury
- Date Received
- June 13, 2007
- Date of Event
- May 7, 2007
- Report Date
- May 14, 2007
- Manufacturer
- ZIMMER, INC.
- Product Code
- HRZ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
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 TIBIAL PLATE WAS IMPLANTED IN 2006. THE DEVICE WAS REVISED IN 2007, DUE TO LOOSENING. DURING REVISION SURGERY, THE SCREWDRIVER BROKE, PROLONGING SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE TIBIAL COMPONENT | KNEE PROSTHESIS | HRZ | ZIMMER, INC. | NA | 60267670 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Hospitalization| R | CATALOG #00588102600 NEXGEN COMPLETE KNEE SOLUTION| ROTATING HINGE KNEE SCREW DRIVER |