BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM SYSTEM

    MDR report key: 6464554 · Received April 6, 2017

    Report

    Report Number
    0001825034-2017-02369
    Event Type
    Injury
    Date Received
    April 6, 2017
    Date of Event
    November 8, 2016
    Report Date
    December 31, 2018
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED (PRODUCT LOCATION UNKNOWN) TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED. CONCOMITANT PRODUCTS- PART: 103209 NAME: TAPERLOC POR FMRL 17.5X155 LOT: 565620; PART: 139256 NAME: M2A-MAGNUM 42-50 TPR INSRT STD LOT: 679340; PART: US157856 NAME: M2A-MAGNUM PF CUP 56ODX50ID LOT: 990940.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADDITIONAL INFORMATION PREVIOUSLY RECEIVED DOES NOT CHANGE OUTCOME OF INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS- PART: US157856 NAME: M2A-MAGNUM PF CUP 56ODX50ID LOT: 990940. PART: 103209 NAME: TAPERLOC POR FMRL 17.5X155 LOT: 565620. PART:139256 NAME: M2A-MAGNUM 42-50 TPR INSRT STD LOT; 679340. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS:0001825034-2017-02384, 0001825034-2017-05234, 0001825034-2017-05248.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE OP PROVIDED OP NOTES CONFIRMED THE REPORTED EVENT. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR. 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, PATIENT UNDERWENT A LEFT HIP REVISION SURGERY APPROXIMATELY 10 YEARS POST IMPLANTATION DUE TO PAIN. DURING THE PROCEDURE, TOXIC LEVELS OF COBALT AND CHROMIUM AND METALLOSIS WERE NOTED.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 10 YEARS POST INITIAL IMPLANTATION DUE TO PAIN, AND METALLOSIS. DURING THE PROCEDURE IT WAS NOTED THAT THERE WERE LARGE OSTEOLYTIC LESIONS ALONG THE POSTERIOR ASPECT OF THE STEM THAT DISTENDED, PROBABLY TWO INCHES WHICH WAS FILLED WITH METAL DEBRIS. THERE WAS ALSO ANOTHER OSTEOLYTIC LESION POSTERIOR TO THE ACETABULUM, FILLED WITH METAL DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246496 M2A MAGNUM SYSTEM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 137430

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R