BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM SYSTEM

    MDR report key: 6449807 · Received March 31, 2017

    Report

    Report Number
    0001825034-2017-02219
    Event Type
    Injury
    Date Received
    March 31, 2017
    Date of Event
    March 21, 2017
    Report Date
    November 20, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED A ZIMMER BIOMET DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE DEVICE(S) INVOLVED IN THE EVENT ARE COMPETITOR PRODUCT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED A ZIMMER BIOMET DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE DEVICE(S) INVOLVED IN THE EVENT ARE COMPETITOR PRODUCT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICE WAS NOT RETURNED SO NO PRODUCT EVALUATION COULD BE CONDUCTED. THIS DEVICE WAS USED FOR TREATMENT. DEVICE HISTORY REPORT WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT PRODUCTS: P/NUS157860 L/N058450 M2A MAGNUM SYSTEM. P/N11-103206 L/N232610 TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM. P/N 157454 L/N 573930 M2A MAGNUM SYSTEM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1825034-2017-02218 AND 1825034-2017-02219.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY APPROXIMATELY 9 YEARS AGO. PATIENT UNDERWENT REVISION 8 YEARS POST IMPLANTATION DUE TO HIP AND GROIN PAIN AS WELL AS POPPING AND CLICKING OF THE HIP COMPONENTS. DURING REVISION SURGERY, SURGEON NOTED AN EARLY FORMATION OF A PSEUDOCYST WITH METAL SHAVINGS WITHIN THE CAPSULE. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY EIGHT YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS. THE PATIENT WAS CONCERNED WITH METAL-ON-METAL ARTICULATION ALTHOUGH EXPERIENCING NO PROBLEMS OR SYMPTOMS WITH HIS IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233236 M2A MAGNUM SYSTEM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 799550

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R