BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM PF CUP

    MDR report key: 6236939 · Received January 10, 2017

    Report

    Report Number
    0001825034-2016-05403
    Event Type
    Injury
    Date Received
    January 10, 2017
    Date of Event
    January 18, 2016
    Report Date
    June 30, 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
    MI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO DEVICES OR PHOTOS OF THE DEVICES WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. ADDITIONALLY, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE PRODUCT NUMBER AND THE LOT NUMBER WERE NOT PROVIDED; THEREFORE, THE MANUFACTURING DATE, THE DEVICE HISTORY RECORDS AND THE FIELD AGE OF THE DEVICE COULD NOT BE DETERMINED. THERE IS INSUFFICIENT INFORMATION TO PERFORM A COMPLAINT HISTORY SEARCH. A DEFINITIVE ROOT CAUSE COULD NOT 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. CONCOMITANT MEDICAL PRODUCTS: 139252/290470, M2A-MAGNUM 42-50 MM, TPR & 15-103200/230510, TAPERLOC MICROP LAT FM. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034-2016-04185-1).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THIS INFORMATION DID NOT CHANGE CONCLUSIONS OF PREVIOUS CONCLUSION. THE INFORMATION CORRECTED IN THIS REPORT WAS ONLY LEFT OUT OF THE PREVIOUS REPORT, NOT THE INVESTIGATION. 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 PROCEDURE APPROXIMATELY 7 YEARS POST-IMPLANTATION DUE TO UNSPECIFIED COMPLICATIONS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE RECORDS RECEIVED INDICATE THAT PATIENT UNDERWENT A REVISION DUE TO MECHANICAL COMPLICATION OF INTERNAL ORTHOPEDIC DEVICE, PAIN, AND FUNCTIONAL LIMITATIONS. DURING THE REVISION, A PSEUDOTUMOR WAS NOTED. THE ACETABULAR SHELL AND MODULAR HEAD WERE REMOVED AND REPLACED, AND A POLYETHYLENE LINER WAS IMPLANTED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS. REVIEW OF INVOICE HISTORY SHOWS THE MODULAR HEAD WAS REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE REPORT INDICATED THE REVISION WAS DUE TO MECHANICAL COMPLICATION OF INTERNAL ORTHOPEDIC DEVICE, PAIN, FUNCTIONAL LIMITATIONS. DURING THE REVISION, PSEUDOTUMOR WAS NOTED, ACETABULAR AND FEMORAL COMPONENTS WERE WELL-FIXED AND MINIMAL TO NO CORROSION NOTED ON THE TRUNNION. THE ACETABULAR SHELL AND MODULAR HEAD WERE REMOVED AND REPLACED; A POLY LINER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20259 M2A MAGNUM PF CUP HIP PROSTHESIS KWA BIOMET ORTHOPEDICS N/A 297280

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R