VANGUARD UNV 5IN1 TIBIAL TRIAL 71/75X10
Received Apr 20, 2012 · Event occurred Mar 21, 2012
Report 0001825034-2012-00496 · MDR key 2543522
Device
Generic name
Template
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
32-483840
Lot number
924740
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Bone Fracture(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012. DURING THE PROCEDURE, AS THE SURGEON WAS TRYING TO INSERT THE TIBIAL BEARING TRIAL, THE BEARING FRACTURED. THE FRACTURED PIECE WAS REMOVED FROM THE PATIENT'S WOUND AND THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY.
Additional Manufacturer Narrative
REVIEW OF RETURNED DEVICE SHOWS THAT BEARING TRIAL EXHIBITS BOTH INDENTATIONS AND A FRACTURE, BUT IT IS UNKNOWN IF THE INDENTATIONS AND FRACTURE OCCURRED AT THE SAME TIME. IT IS CONCEIVABLE THAT USER TECHNIQUES AND TOOL IMPACT FORCES THAT CREATED THE INDENTATIONS COULD HAVE EVENTUALLY CONTRIBUTED TO THE FRACTURE. THERE ARE STRONG VISUAL SIGNS THAT THE TRIAL BEARING WAS FORCED INTO SPACES BETWEEN THE FEMORAL AND TIBIAL TRAY THAT WERE TOO NARROW TO ACCOMMODATE IT.
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.