OFFSET TIB TRAY ADAPTER PLUG
Received Apr 22, 2015 · Event occurred Mar 27, 2015
Report 0001825034-2015-01685 · MDR key 4721028
Device
Generic name
Prosthesis, Knee
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
141492
Lot number
974030
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
56 YR
- Unspecified Infection
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2015. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2015 DUE TO INFECTION. ALL PRODUCTS WERE REMOVED AND CEMENT SPACER MOLDS WERE USED TO COMPLETE THE PROCEDURE.
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 COMPLAINT RELATED ANOMALY OR DEVIATION. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. 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.¿ THIS REPORT IS NUMBER 1 OF 7 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015- 01685 / 01691).