FDA Adverse Event
Injury
Summary report: N
UNKNOWN NEXGEN ROTATING HINGE KNEE
MDR report key: 1561182
·
Received December 16, 2009
Report
- Report Number
- 1822565-2009-01199
- Event Type
- Injury
- Date Received
- December 16, 2009
- Date of Event
- October 23, 2009
- Report Date
- November 16, 2009
- Manufacturer
- ZIMMER, INC.
- Product Code
- HRZ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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 THE DEVICES WERE IMPLANTED IN 2004, AND THE PATIENT WAS REVISED IN 2009, DUE TO SUBLUXATION, PAINFUL JOINT BLOCK AND DISLOCATION OF STUD. NO INDICATION OF TRAUMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN NEXGEN ROTATING HINGE KNEE | KNEE PROSTHESIS | HRZ | ZIMMER, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Hospitalization| R |