FDA Adverse Event
Injury
Summary report: N
EIUS UNI KNEE MED FEM LM/RL
MDR report key: 1881172
·
Received October 20, 2010
Report
- Report Number
- 9610726-2010-00367
- Event Type
- Injury
- Date Received
- October 20, 2010
- Date of Event
- September 29, 2010
- Report Date
- September 29, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- HSX
- PMA / PMN Number
- K992287
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PT WAS BROUGHT TO THE OPERATING ROOM FOR REVISION OF UNI KNEE. IMPLANTS WERE REMOVED WITH OSTEOTOMES AND A PRIMARY TRIATHLON TOTAL KNEE WAS IMPLANTED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EIUS UNI KNEE MED FEM LM/RL | IMPLANT | HSX | STRYKER ORTHOPAEDICS LIMERICK | NA | LPYKP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |