BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD 48MM HEAD DIAMETER

    MDR report key: 6013606 · Received October 10, 2016

    Report

    Report Number
    0001825034-2016-04001
    Event Type
    Injury
    Date Received
    October 10, 2016
    Date of Event
    February 1, 2016
    Report Date
    August 7, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    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. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-04001 / 04002).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL PRODUCTS - M2A MAGNUM CUP CATALOG#: US157854 LOT#: 191440, TAPERLOC STEM CATALOG#: 15-103207 LOT#: 703780, M2A MAGNUM TAPER ADAPTER CATALOG#: 139256 LOT#: 556390. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED NO ACTION IS NECESSARY AS NO TRENDS WERE IDENTIFIED. MEDICAL RECORDS INDICATE THE PATIENT WAS REVISED FOR PAIN, NERVE DAMAGE AND ABDUCTOR TENDON REPAIR; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION 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

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT LEFT HIP REVISION APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS. 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

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT LEFT HIP REVISION APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. IT WAS REPORTED IN MEDICAL RECORDS RECEIVED THAT PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY 7 YEARS POST-IMPLANTATION DUE TO A FAILED IMPLANT. DURING THE PROCEDURE, THE PATIENT UNDERWENT AN ABDUCTOR REPAIR. THE FEMORAL HEAD, TAPER ADAPTER, AND STEM WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCT. PATIENT IS EXPERIENCING ONGOING PAIN WITH NERVE DAMAGE RELATED TO THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666018 M2A MAGNUM MODULAR HEAD 48MM HEAD DIAMETER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 246910

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R