BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SHOULDER INSTRUMENT PRIMARY SHOULDER STEM INSERTER

    MDR report key: 2212113 · Received August 15, 2011

    Report

    Report Number
    1825034-2011-00721
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).BASED ON THE DESCRIPTION OF THE EVENT, IT WAS DETERMINED THAT IT SHOULD HAVE BEEN REPORTED AS A SERIOUS INJURY.THIS REPORT FILED (B)(4), 2011.

    Additional Manufacturer Narrative · 1

    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. THERE ARE WARNINGS IN THE ASSOCIATED PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "SPECIALIZED INSTRUMENTS ARE DESIGNED FOR BIOMET JOINT REPLACEMENT SYSTEMS TO AID IN THE ACCURATE IMPLANTATION OF THE PROSTHETIC COMPONENTS... BIOMET RECOMMENDS THAT ALL INSTRUMENTS BE REGULARLY INSPECTED FOR WEAR AND DISFIGUREMENT." REVIEW OF SALES HISTORY INDICATES THAT THE INSTRUMENT WAS DISTRIBUTED IN 2008. ADDITIONAL INFORMATION PERTAINING TO REPAIR HISTORY REVEALED THAT THE INSTRUMENT HAS NOT BEEN RETURNED FOR REPAIR SINCE IT WAS CONSIGNED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A SHOULDER ARTHROPLASTY PROCEDURE UTILIZING A STEM INSERTER ON (B)(6) 2011. DURING THE PROCEDURE, THE INSERTER WOULD NOT DISENGAGE FROM THE IMPLANT AFTER THE IMPLANT WAS IMPACTED. THE INSERTER AND IMPLANT WERE REMOVED AND DISENGAGED. THE IMPLANT WAS CEMENTED INTO PLACE AND THE SURGERY WAS COMPLETED WITHOUT INJURY TO THE PATIENT OR SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPREHENSIVE SHOULDER INSTRUMENT PRIMARY SHOULDER STEM INSERTER ORTHOPEDIC, MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A 867520

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R