BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 3771264 · Received April 24, 2014

    Report

    Report Number
    0001825034-2014-03270
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 24, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK120121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS IT STATES, "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS." DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, IT WAS NOTED THE COMPONENT EXHIBITS A SHIFT IN THE TAPER LOCATION DUE TO IMPACTION. THE ROOT CAUSE OF THE EVENT WAS DETERMINED TO MOST LIKELY BE DUE TO IMPROPER PLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A COMPREHENSIVE REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014, DUE TO THE GLENOSPHERE DISASSOCIATING FROM THE GLENOID BASEPLATE. SURGEON NOTED THE DISASSOCIATION WAS DUE TO THE PLACEMENT OF THE GLENOSPHERE. THE HUMERAL BASEPLATE, GLENOSPHERE AND HUMERAL BEARING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249321 COMP RVRS 25MM BSPLT HA+ADPTR PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 066700

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R