FDA Adverse Event
Injury
Summary report: N
BIOMED
MDR report key: 560723
·
Received December 13, 2004
Report
- Report Number
- 560723
- Event Type
- Injury
- Date Received
- December 13, 2004
- Date of Event
- January 24, 2002
- Report Date
- December 13, 2004
- Manufacturer
- BIOMET
- Product Code
- HSH
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
IN 2000 PT HAD SURGERY-RIGHT KNEE DIAGNOSITC ARTHROSCOPY WITH MEDIAL PARTIAL KNEE RESURFACING. PT TOLERATED SURGERY WELL. IN 2002 PT WAS ADMITTED FOR REVISION OF PKR. DIAGNOSTIC ARTHROSCOPY/PLASTIC SKIN CLOSURE. THE OPERATIVE FINDINGS THE MEDIAL COMPARTMENT WAS INSPECTED. THERE WAS NOTED TO BE PREMATURE WEAR OF THE POLYETHYLENE TIBIAL COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOMED | REPICC II KNEE TIBIAL COMPONENT | HSH | BIOMET | REPICCI II KNEE TIBIAL COMPONET | 282110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization | REPICCI II KNEE FEMORAL COMPONENT: 48MM,| RIGHT MEDICAL/LEFT LATERAL CO-CR-MO-ALLAN |