BIOMET OFFSET TIBIAL TRAY ADAPTOR NEUTRAL
Received Sep 8, 2011 · Event occurred Aug 1, 2011
Report 1825034-2011-00798 · MDR key 2239815
Device
Generic name
Prosthesis, Knee
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
141489
Lot number
526770
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- Fall
- Unspecified Infection
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PATIENT WITH A HISTORY OF INFECTION AND REVISION PROCEDURES UNDERWENT A REVISION KNEE ARTHROPLASTY ON (B)(6), 2010 DUE TO A FALL. A SUBSEQUENT REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2011 TO REMOVE AND REPLACE ALL KNEE COMPONENTS WITH ANTIBIOTIC SPACERS DUE TO INFECTION. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.
Additional Manufacturer Narrative
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 DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO (B)(4). 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 IS NUMBER 7 OF 8 MDRS FILED FOR THE SAME PATIENT / EVENT(S) (REFERENCE 1825034-2011-00792 / 00799). THIS REPORT FILED (B)(4), 2011.