BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD SZ 50MM

    MDR report key: 3994323 · Received August 8, 2014

    Report

    Report Number
    0001825034-2014-06903
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THESE TYPES OF EVENTS CAN OCCUR. UNDER POSSIBLE ADVERSE EFFECTS IT STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN" AND "LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY". THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL MEDWATCH FOR THE SAME EVENT REPORTED ON A DIFFERENT PRODUCT (REFERENCE 1825034-2014-07623).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THESE TYPES OF EVENTS CAN OCCUR: "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT ALLEGES PAIN, VIBRATION AND IMPLANT POPPING/SQUEAKING. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE UNDERGONE A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT REPORTS POPPING, GRINDING, PAIN AND AUDIBLE NOISES COMING FROM THE JOINT. PATIENT FURTHER REPORTS RADIOGRAPHS REVEALED THE ACETABULAR CUP HAS SHIFTED FROM ITS ORIGINAL POSITION. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE UNDERGONE A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT REPORTS POPPING, GRINDING, PAIN AND AUDIBLE NOISES COMING FROM THE JOINT. PATIENT FURTHER REPORTS RADIOGRAPHS REVEALED THE ACETABULAR CUP HAS SHIFTED FROM ITS ORIGINAL POSITION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED REPORTS PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 ALLEGEDLY DUE TO ASEPTIC LOOSENING AND MALPOSITIONED CUP. THE CUP, HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472455 M2A-MAGNUM MODULAR HEAD SZ 50MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 873530

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention