FDA Adverse Event
Injury
Summary report: N
NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE ARTICULAR SURFACE WITH HINGE P
MDR report key: 1567081
·
Received December 23, 2009
Report
- Report Number
- 1822565-2009-01250
- Event Type
- Injury
- Date Received
- December 23, 2009
- Date of Event
- September 21, 2009
- Report Date
- September 23, 2009
- Manufacturer
- ZIMMER, INC.
- Product Code
- HRZ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- 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 DEVICES WERE IMPLANTED IN 2009 AND THAT THE PT WAS REVISED THE FOLLOWING MONTH, DUE TO INFECTION. UPON REVISING THE SURFACE, THE SURGEON HAD TO REPLACE THE FEMORAL SVC PARTS DUE TO THE HINGE PARTS BEING WELDED TOGETHER. ONCE THE SURFACE WAS REMOVED, IT WAS NOTICED THAT THERE WAS A SHARD PIECE OF METAL IMBEDDED IN THE SURFACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE ARTICULAR SURFACE WITH HINGE P | KNEE PROSTHESIS | HRZ | ZIMMER, INC. | NA | 61145556 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R | FEMORAL HINGE SERVICE KIT, CATALOG #00588009013| LOT #61159317| NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE |