BIOMET OFFSET TIBIAL TRAY 71MM
Received Dec 12, 2013 · Event occurred Nov 7, 2013
Report 0001825034-2013-05754 · MDR key 3517801
Device
Generic name
Prosthesis, Knee
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
141483
Lot number
894320
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Unspecified Infection
Narrative
Description of Event or Problem
IT WAS REPORTED A PATIENT UNDERWENT A KNEE REVISION OF COMPETITOR PRODUCT ON (B)(6) 2010. SUBSEQUENTLY, THE PATIENT WAS REVISED (B)(6) 2013 DUE TO INFECTION. SURGEON PERFORMED JOINT WASH OUT AND THE POLYETHYLENE BEARING WAS REMOVED AND REPLACED. ADDITIONALLY, THE PATIENT WAS REVISED ON (B)(6) 2013 DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS. NO ADDITIONAL INFORMATION HAS BEEN REPORTED 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, ¿EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION.¿ REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH (B)(4). THIS REPORT IS NUMBER 2 OF 11 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-05753/05763).