BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD SZ 42MM

    MDR report key: 3931612 · Received July 14, 2014

    Report

    Report Number
    0001825034-2014-06143
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 13, 2014
    Report Date
    September 15, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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: "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06143 & 06144).

    Additional Manufacturer Narrative · 1

    THE RETURNED HEAD AND CUP WERE EVALUATED AND WAS FOUND TO HAVE BEEN MANUFACTURED WITHIN SPECIFICATIONS. VISUAL EXAMINATION OF HEAD AND CUP APPEARED TO SHOW EVIDENCE OF DAMAGE CONSISTENT WITH THE REPORTED CUP DISLOCATION. THE HEAD AND CUP APPEARED TO SHOW EVIDENCE OF SUBLUXATION OF THE JOINT, SCRATCHING OF THE BEARING SURFACES AND POSSIBLE METALLIC TRANSFER MARKS. ALTHOUGH IT APPEARS THAT SOME TYPE OF THIRD BODY PARTICLE WAS PRESENT, THE SOURCE AND IDENTITY OF THIS AGENT COULD NOT BE ESTABLISHED DURING VISUAL EXAMINATION. EVALUATION WAS UNABLE TO IDENTIFY THE ROOT CAUSE FOR DISLOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO DISLOCATION. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND THE STEM REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410832 M2A-MAGNUM MODULAR HEAD SZ 42MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 872640

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R