BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 52-60MM TAPER INSERT-3

    MDR report key: 6290971 · Received January 31, 2017

    Report

    Report Number
    0001825034-2017-00303
    Event Type
    Injury
    Date Received
    January 31, 2017
    Date of Event
    January 8, 2013
    Report Date
    January 26, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    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 THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. MEDICAL PRODUCT - BIOMET M2A-MAGNUM CUP ITEM #: US157858 LOT#: 600540; BIOMET TAPERLOC CATALOG#: 11-103207 LOT#: 061520.

    Description of Event or Problem · 1

    PATIENT REPORTED A RIGHT HIP REVISION APPROXIMATELY 4 YEARS POST-IMPLANTATION DUE TO UNSPECIFIED ALLEGATIONS. DURING THE PROCEDURE, THE FEMORAL HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED AND AN ACTIVE ARTICULATION BEARING WAS IMPLANTED. ADDITIONAL INFORMATION RECEIVED IN PATIENT'S MEDICAL RECORDS INDICATES THE PATIENT WAS REVISED DUE TO EVIDENCE OF A PSEUDOTUMOR AND AN ASEPTIC HIP. REVISION OPERATIVE REPORT NOTED EXCISION OF THE PSEUDOTUMOR, DEBRIDEMENT OF SCAR TISSUE AND DEBRIS, AND CORROSION AT THE HEAD AND TAPER JUNCTION.

    Description of Event or Problem · 1

    PATIENT REPORTED A RIGHT HIP REVISION APPROXIMATELY 4 YEARS POST-IMPLANTATION DUE TO UNSPECIFIED ALLEGATIONS. DURING THE PROCEDURE, THE FEMORAL HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED AND AN ACTIVE ARTICULATION BEARING WAS IMPLANTED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71817 M2A-MAGNUM 52-60MM TAPER INSERT-3 PROTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 875170

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R