BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 52ODX46ID

    MDR report key: 3800254 · Received May 8, 2014

    Report

    Report Number
    0001825034-2014-03761
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    February 3, 2016
    Report Date
    September 14, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 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 1825034-2014-03761 / 03762).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION: CONCOMITANT PRODUCTS - NAME: M2A-MAGNUM MOD HD SZ 46MM PART: 157446 LOT: 342940.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT AND SHOULD NOT HAVE BEEN REPORTED. THE INITIAL REPORT SHOULD BE VOIDED AS IT WAS SUBMITTED IN ERROR.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. LEGAL COUNSEL FURTHER REPORTS PATIENT ALLEGATIONS OF PAIN, DEBILITATION, ELEVATED METAL ION LEVELS, DISCOMFORT, INFLAMMATION, DYSFUNCTION, LOSS OF RANGE OF MOTION, LOSS OF MOBILITY, METAL POISONING, AND METALLOSIS. THERE HAS BEEN NO REPORTED REVISION TO DATE. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 8 YEARS POST INITIAL IMPLANTATION DUE TO PAIN AND ELEVATED METAL IONS. DURING THE PROCEDURE THE SURGEON NOTED THAT THERE WAS A SIGNIFICANT AMOUNT OF FLUID IN THE JOINT AND THICKENING OF HER CAPSULE. THE FEMORAL HEAD WAS THE ONLY PRODUCT THAT WAS REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILIBLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277816 M2A-MAGNUM PF CUP 52ODX46ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 782650

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R