BIOMET OFFSET TIBIAL TRAY 79MM
Received Jun 19, 2012 · Event occurred May 22, 2012
Report 0001825034-2012-00866 · MDR key 2621118
Device
Generic name
Prosthesis, Knee
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
141485
Lot number
022590
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Unspecified Infection
- No Code Available
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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER TWO STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION". REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS NUMBER 5 OF 10 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00862 / 00871).
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT KNEE PROCEDURE ON (B)(6), 2011. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6), 2012, DUE TO INFECTION. ALL IMPLANTS WERE REMOVED AND REPLACED WITH ANTIBIOTIC CEMENT SPACERS.