BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD -6MM NK

    MDR report key: 3903412 · Received June 30, 2014

    Report

    Report Number
    0001825034-2014-05860
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 9, 2014
    Report Date
    September 26, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED CUP WAS EVALUATED AND WAS FOUND TO HAVE BEEN MANUFACTURED WITHIN SPECIFICATIONS. VISUAL EXAMINATION OF THE CUP SHOWED EVIDENCE OF SCRATCHING OF THE BEARING SURFACE WITH POSSIBLE EVIDENCE OF EDGE WEAR. DIMENSIONAL ANALYSIS OF THE INTERNAL FEATURES OF THE CUP FOUND ALL FEATURES TO BE CONFORMING EXCEPT FOR THE ROUNDNESS. THE ROUNDNESS CAN BE AFFECTED BY SEVERAL FACTORS ONCE THE COMPONENT IS IN THE FIELD. THIS FEATURE IS MEASURED 100% DURING THE MANUFACTURE OF THE COMPONENT. ADDITIONALLY, NO OTHER COMPONENTS WERE RETURNED FOR EVALUATION. IT IS LIKELY THAT THE COMPONENT WAS CONFORMING WHEN IT LEFT BIOMET CONTROL. ROOT CAUSE CANNOT BE IDENTIFIED AT THIS TIME DUE TO INSUFFICIENT 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 THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THESE TYPES OF EVENTS CAN OCCUR UNDER POSSIBLE ADVERSE EFFECTS: INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, PATIENT¿S HIP WAS REVISED ON (B)(6) 2014 DUE TO ALLEGATIONS OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379341 M2A 38MM MOD HD -6MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 205320

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R