BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 54ODX48ID

    MDR report key: 3840352 · Received May 30, 2014

    Report

    Report Number
    0001825034-2014-05038
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 1, 2012
    Report Date
    July 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
    FL, US
    Reporter Occupation
    ATTORNEY

    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 1 STATES, ¿MATERIAL SENSITIVITY REACTIONS.¿ NUMBER 6 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ NUMBER 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ NUMBER 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.¿ THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05038 / 05039).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CORRECTION: COMPONENT REMAINS IMPLANTED. THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05038 / -05039 AND -06863 / -06864).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A REVISION PROCEDURE ON (B)(46 2012, DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, METALLOSIS, ELEVATED METAL ION LEVELS, DAMAGE TO SURROUNDING BONE AND TISSUE, AND LACK OF MOBILITY. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A REVISION PROCEDURE ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, METALLOSIS, ELEVATED METAL ION LEVELS, DAMAGE TO SURROUNDING BONE AND TISSUE, AND LACK OF MOBILITY. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT'S MEDICAL RECORDS REPORTS PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 WITH NO REPORTED REVISION PROCEDURE AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003, WHICH WAS REVISED (B)(6) 2012. ADDITIONAL INFORMATION RECEIVED IN PATIENT'S OPERATIVE (OP) NOTES REPORTS PATIENT WAS REVISED ON THE LEFT HIP DUE TO PAIN AND ELEVATED METAL ION STUDIES. REVISION OP REPORT NOTES THE ACETABULUM WAS FOUND WELL-FIXED BUT IN A LATERAL POSITION. OP NOTES ALSO REPORT ARTICULAR SURFACE WEAR, SOFT BONE, AND AN ACETABULAR CYST. THE CUP AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318370 M2A-MAGNUM PF CUP 54ODX48ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 532340

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R