FDA Adverse Event
Injury
Summary report: N
BIOMET ARCOM AP PATELLA 3-PEG
MDR report key: 1081143
·
Received July 15, 2008
Report
- Report Number
- 1825034-2008-00195
- Event Type
- Injury
- Date Received
- July 15, 2008
- Date of Event
- June 2, 2008
- Report Date
- June 25, 2008
- Manufacturer
- BIOMET, INC.
- Product Code
- JWH
- PMA / PMN Number
- K921182
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT PT UNDERWENT LEFT KNEE REVISION PROCEDURE IN 2008. UPON ENTERING THE KNEE, MODERATELY ADVANCED METALLOSIS WITH DARKENING OF THE SYNOVIUM WAS PRESENT IN THE SUPRAPATELLAR POUCH AND LATERAL RECESSES AND EXTENSIVE SYNOVECTOMY WAS PERFORMED. POLYETHYLENE TIBIAL BEARING AND PATELLA BUTTON COMPONENTS WERE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOMET ARCOM AP PATELLA 3-PEG | JWH | JWH | BIOMET, INC. | NA | 490000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Hospitalization| R |