COMPREHENSIVE INSTRUMENTION HUMERAL TRIAL 44MM STANDARD - 36MM STANDARD
Received Apr 3, 2012 · Event occurred Mar 5, 2012
Report 0001825034-2012-00360 · MDR key 2514231
Device
Generic name
Device, Prosthesis Alignment
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
405940
Lot number
477810
Product problems
- Detachment Of Device Component
- Fracture
Patient
Not reported
- No Code Available
Narrative
Additional Manufacturer Narrative
THE PHYSICAL CONDITION OF THE TRIAL SUGGESTS INTERACTION WITH A SHARP SURGICAL INSTRUMENT AND THE FRACTURE OF THE DEVICE WAS CAUSED BY BENDING OVERLOAD. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6), 2012. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA.
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT REVERSE SHOULDER ARTHROPLASTY ON (B)(6), 2012. DURING THE FINAL TRIAL REDUCTION PHASE, THE POST FRACTURED OFF THE TRIAL BEARING, AND HAD TO BE THE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO SIGNIFICANT DELAY TO THE PROCEDURE, AND NO FOREIGN BODIES WERE RETAINED BY THE PATIENT.