BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 50MM

    MDR report key: 4101582 · Received September 19, 2014

    Report

    Report Number
    0001825034-2014-07813
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    December 14, 2012
    Report Date
    December 4, 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
    LA, 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 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.¿ THIS REPORT IS BASED ON PATIENT ALLEGATIONS AND THE ALLEGATIONS ARE CURRENTLY UNKNOWN AND UNVERIFIED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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.¿ THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-07813 AND 09218).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, POPPING/CLICKING, LACK OF MOBILITY AND LOSS OF RANGE OF MOTION. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON PATIENT ALLEGATIONS AND THE ALLEGATIONS ARE CURRENTLY UNKNOWN AND UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, POPPING/CLICKING, LACK OF MOBILITY AND LOSS OF RANGE OF MOTION. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON PATIENT ALLEGATIONS AND THE ALLEGATIONS ARE CURRENTLY UNKNOWN AND UNVERIFIED. ADDITIONAL INFORMATION IN PATIENT MEDICAL RECORDS REVEAL THE (B)(6) 2012 REVISION WAS DUE TO PAIN, WEAR, AND ASEPTIC LOOSENING. THE PATIENT'S OPERATIVE REPORT NOTED METALLOSIS, FLUID WITH METAL DEBRIS, SYNOVIAL-TYPE TISSUE, PSEUDOTUMOR, OSTEOLYSIS, AND A RETROVERTED CUP. THE CUP, MODULAR HEAD AND TAPER ADAPTER WERE REMOVED. THE CUP WAS REPLACED WITH A COMPETITOR'S. THE HEAD AND TAPER ADAPTER WERE REPLACED WITH BIOMET COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585027 M2A-MAGNUM MOD HD SZ 50MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 855860

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R