COMPREHENSIVE INSTRUMENTATION HUMERAL TRIAL 44MM STANDARD - 36 MM STANDARD
Received Jul 17, 2012 · Event occurred Jun 21, 2012
Report 0001825034-2012-01052 · MDR key 2657269
Device
Product problems
- Fracture
- Device Dislodged or Dislocated
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
IT WAS REPORTED PATIENT UNDERWENT A COMPREHENSIVE REVERSE SHOULDER ARTHROPLASTY ONE MONTH PRIOR TO REVISION. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6), 2012 DUE TO FRACTURE AND DISLOCATION. DURING THE PROCEDURE, INSTRUMENT WHICH SEATS THE TRIAL IN PLACE FRACTURED.
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. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER PRECAUTIONS IT STATES, "INSTRUMENTS THAT HAVE EXPERIENCED EXTENSIVE USE OR EXCESSIVE FORCE ARE SUSCEPTIBLE TO FRACTURE. SURGICAL INSTRUMENTS SHOULD ONLY BE USED FOR THEIR INTENDED PURPOSE. BIOMET RECOMMENDS THAT ALL INSTRUMENTS BE REGULARLY INSPECTED FOR WEAR AND DISFIGUREMENT." THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01049).