BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD SZ 46MM

    MDR report key: 4759556 · Received May 8, 2015

    Report

    Report Number
    0001825034-2015-01978
    Event Type
    Injury
    Date Received
    May 8, 2015
    Date of Event
    April 14, 2015
    Report Date
    July 28, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT - BIOMET M2A TAPER ADAPTER CATALOG#: 139254, LOT#: 427380; BIOMET FEMORAL STEM, CATALOG#: 13-103209, LOT#: 821880.

    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 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 1825034-2015-01978 & 01980).

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP REVISION PROCEDURE APPROXIMATELY EIGHT YEARS POST-IMPLANTATION DUE TO ELEVATED METAL ION LEVELS, METAL WEAR AND PAIN. DURING THE PROCEDURE, BLACK SOFT TISSUE AND FLUID, OSTEOLYTIC LESIONS AND ADVERSE TISSUE REACTION WERE NOTED. THE ACETABULAR CUP, MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED WITH A BIOMET HEAD AND A LEGACY ZIMMER CUP AND LINER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2015 DUE TO ELEVATED METAL ION LEVELS AND PAIN. DURING THE PROCEDURE, BLACK SOFT TISSUE WAS NOTED. THE ACETABULAR CUP, MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED WITH A BIOMET HEAD AND A COMPETITOR CUP AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304357 M2A-MAGNUM MODULAR HEAD SZ 46MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 427470

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R