BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC MICROP LAT FMRL 7.5MM

    MDR report key: 3568012 · Received January 10, 2014

    Report

    Report Number
    0001825034-2014-00191
    Event Type
    Injury
    Date Received
    January 10, 2014
    Date of Event
    November 8, 2010
    Report Date
    July 31, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK062994
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.THE STEM REMAINS IMPLANTED AND WAS NOT REVISED AS PREVIOUSLY REPORTED.(B)(4)

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, ¿MATERIAL SENSITIVITY REACTIONS.¿ NUMBER 6 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ NUMBER 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ IT IS UNKNOWN IF PRODUCT WAS REMOVED DURING THE REVISION PROCEDURE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-00188 / 00191).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION. EVENT DATE - 2014, EXPLANT DATE - 2014, THERAPY DATE - 2014. REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF PHOTOGRAPHS AND VISUAL EXAMINATION. A FATIGUE CRACK CAN BE SEEN RADIATING FROM THE SUPERIOR SURFACE OF THE TAPER. A LARGE AMOUNT OF DEBRIS CAN BE SEEN AROUND THE CIRCUMFERENCE OF THE TAPER AND A REDUCTION IN AREA OF THE FRACTURE SURFACE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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 THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, ELEVATED COCR LEVELS, METALLOSIS AND METAL POISONING. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION ON (B)(6) 2010. 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

    IT WAS REPORTED THAT PATIENT WAS REVISED APPROXIMATELY 5 YEARS POST-IMPLANTATION DUE TO FRACTURE OF THE FEMORAL STEM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18434 TAPERLOC MICROP LAT FMRL 7.5MM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 308940

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R