MAXIM MODULAR TIBIAL AUGMENTATION BLOCK W / SCREWS 6MM X 79MM
Received Apr 4, 2011 · Event occurred Feb 28, 2011
Report 1825034-2011-00243 · MDR key 2038433
Device
Generic name
Prosthesis, Knee
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
141745
Lot number
861470
Product problems
- Device Slipped
Patient
Not reported
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFORMATION 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. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICES WERE STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "EARLY OR LATE POSTOPERATIVE, INFECTION, AND ALLERGIC REACTION." THIS REPORT FILED (B)(6), 2011.
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT REVISION KNEE ARTHROPLASTY ON (B)(6), 2010 DUE TO TIBIAL SUBSIDENCE. A SUBSEQUENT REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2011 DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.