BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 1 PC SHELL 38MMX52MM

    MDR report key: 4091793 · Received September 16, 2014

    Report

    Report Number
    0001825034-2014-07697
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.¿ THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-07696 / 07697).

    Additional Manufacturer Narrative · 1

    THE RETURNED HEAD AND CUP WERE FOUND TO HAVE BEEN MANUFACTURED WITHIN SPECIFICATIONS. VISUAL EXAMINATION OF THE HEAD AND CUP APPEARED TO SHOW EVIDENCE OF SUBLUXATION OF THE JOINT AND SCRATCHING OF THE BEARING SURFACES. RELEVANT ARTICULATING AND STACK DIMENSIONS AND FEATURES WERE CHECKED. ALL MEASUREMENTS WERE WITHIN THE AS MANUFACTURED REQUIREMENTS. THE LENGTH OF SERVICE IS 6+ YEARS, AND THE REMOVAL IS TYPICAL IF THERE IS A METAL ION CONCERN IN THIS AREA. THERE IS NO INDICATION, WITH THE INFORMATION AVAILABLE, THAT THERE IS ANY NON-CONFORMANCE IN THE PRODUCTS AS MANUFACTURED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO ARMD AND ELEVATED METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573263 M2A 1 PC SHELL 38MMX52MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 005260

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R