OFFSET TIBIAL TRAY 5.0MM ADAPTOR
Received Nov 22, 2011 · Event occurred Oct 26, 2011
Report 0001825034-2011-01023 · MDR key 2345100
Device
Generic name
Prosthesis, Knee
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
141491
Lot number
013640
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Unspecified Infection
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT KNEE ARTHOPLASTY ON (B)(6), 2010, SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6), 2011, DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED.
Additional Manufacturer Narrative
THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED 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 #2 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 3 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2011-01021 - 01026).