BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM TAPER ADAPATER 42-50MM PLUS 3MM

    MDR report key: 5984225 · Received September 28, 2016

    Report

    Report Number
    0001825034-2016-03848
    Event Type
    Injury
    Date Received
    September 28, 2016
    Date of Event
    July 31, 2014
    Report Date
    September 18, 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
    AL, 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 6 OF 8 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-03843 / 03844 / 03845 / 03846 / 03847 / 03848 / 03849 / 03850).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS NUMBER 14 STATES; INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS: TAPERLOC POR FMRL 10X140 CATALOG# 103204 LOT# 957930; M2A-MAGNUM 42-50M TPR INSRT +3 CATALOG#139258 LOT#815520; M2A-MAGNUM PF CUP 56OD/50ID CATALOG# US157856 LOT#395470; M2A-MAGNUM MOD HD SZ 50MM CATALOG#157450 LOT #193270. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. REVIEW OF INITIAL OP NOTES DATED (B)(6) 2008 INDICATED PATIENT UNDERWENT AN INITIAL LEFT THA PROCEDURE SUCCESSFULLY WITH NO COMPLICATIONS. IMPLANTS GAVE GOOD FIT AND STABILITY THROUGH FULL RANGE OF MOTION. DURING THE REVISION PROCEDURE IT WAS NOTED THAT FEMORAL HEAD WAS REMOVED EASILY BUT THE TAPER SLEEVE CAUSED DIFFICULTY REMOVING FROM THE STEM. IT WAS NOTED IN THE PROCESS TO DISENGAGE THE TAPER SLEEVE FROM TRUNNION AND DUE TO SURGEON'S REPEATED MALLET BLOWS THE FEMORAL STEM WAS LOOSENED. THE STEM WAS REMOVED AND IT WAS NOTED THERE BONE INGROWTH ALL AROUND. IT WAS ALSO NOTED THAT THE GREATER TROCHANTERIC FRACTURE DID OCCURRED DUE TO THIS. INTRA OPERATIVE X-RAY CONFIRMED THERE WERE NO FRACTURES DISTALLY ON THE FEMUR OTHER THAN THE GREATER TROCHANTER. DUE TO THIS PATIENT HAS TO UNDERGO "OPEN REDUCTION INTERNAL FIXATION OF A GREATER TROCHANTERIC FRACTURE". ALL THE COMPONENTS ARE REMOVED AND REPLACED. NOTHING ABOUT DELAY IN THE PROCEDURE IS MENTIONED IN THE OP NOTES. DEVICE HISTORY RECORD 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 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    OPERATIVE RECORD RECEIVED FROM PATIENT'S LEGAL COUNSEL REPORTED DURING A LEFT HIP REVISION PROCEDURE, THE TAPER SLEEVE WAS COLD WELDED ON THE TRUNNION AND COULD NOT BE REMOVED. ADDITIONAL INSTRUMENTATION WAS REQUIRED TO REMOVED THE DEVICE AND THE STEM HAD TO BE REMOVED. AS A RESULT OF THE STEM REMOVAL, THE PATIENT EXPERIENCED A FRACTURE OF THE GREATER TROCHANTER. CABLES WERE IMPLANTED TO STABILIZE THE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636288 M2A MAGNUM TAPER ADAPATER 42-50MM PLUS 3MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 815520

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention