BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MODULAR HEAD COMPONENT 38MM HEAD DIAMETER PLUS 3MM NECK

    MDR report key: 6322540 · Received February 10, 2017

    Report

    Report Number
    0001825034-2017-00592
    Event Type
    Injury
    Date Received
    February 10, 2017
    Date of Event
    September 24, 2015
    Report Date
    December 13, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS- RD118848 660980 M2A-38 CUP 48 MM. 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." AND, "IT HAS BEEN REPORTED THAT WEAR DEBRIS MAY INITIATE A CELLULAR RESPONSE RESULTING IN OSTEOLYSIS OR OSTEOLYSIS MAY BE A RESULT OF LOOSENING OF THE IMPLANT." NUMBER 14 STATES ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. WEIGHT - NI.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS: IMPACT METAPHYSEAL SIZE 1 MED CATALOG#: 112091 LOT#: 095930; R/H IMPACT DISTAL 10MMX120MM CATALOG#: 11-112010 LOT#: 873260; M2A-38 CUP 48MM CATALOG#: RD118848 LOT#: 660980. REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT¿S RIGHT HIP WAS REVISED APPROXIMATELY 12 YEARS POST-IMPLANTATION ALLEGEDLY DUE TO PAIN, ELEVATED METAL ION LEVELS, AND METALLOSIS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN THE PATIENT¿S REVISION OPERATIVE REPORT CONFIRMED PATIENT WAS REVISED 12 YEARS POST-IMPLANTATION DUE TO METALLOSIS. THE OPERATIVE REPORT NOTED FEMORAL OSTEOLYSIS. THE FEMORAL HEAD WAS REMOVED AND REPLACED AND AN ACETABULAR BEARING WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104634 M2A MODULAR HEAD COMPONENT 38MM HEAD DIAMETER PLUS 3MM NECK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 833850

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R