OFFSET TIB TRAY 2.5MM ADAPTOR
Received Jan 14, 2014 · Event occurred Dec 9, 2013
Report 0001825034-2014-00357 · MDR key 3575294
Device
Generic name
Prosthesis, Knee
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
141490
Lot number
477150
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Unspecified Infection
Narrative
Description of Event or Problem
IT WAS REPORTED A PATIENT UNDERWENT LEFT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2012 DUE TO AN UNKNOWN REASON. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A TOTAL KNEE SYSTEM. ADDITIONALLY, THE PATIENT WAS REVISED ON (B)(6) 2013 DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS.
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 ISO 11137-2. THIS REPORT IS NUMBER 2 OF 7 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-00356/00362).