BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MODULAR HEAD COMPONENT 38MM HEAD DIAMETER STANDARD NECK

    MDR report key: 6139879 · Received December 1, 2016

    Report

    Report Number
    0001825034-2016-04977
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    November 24, 2014
    Report Date
    July 26, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    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

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: M2A-38 ACETABULAR CUP P/N RD118850 L/N 121850; BI-METRIC CDH POROUS STEM P/N 162307 L/N 107000. THE REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS AND ANALYSIS OF THE RETURNED DEVICE. VISUAL EXAMINATION SHOWED SOME SCRATCHES AND SLIGHT DEFORMATION THAT WAS MOST LIKELY CAUSED BY REMOVAL OF THE DEVICE. THE PART WAS CHECKED ON A ZYGO FOR SPHERICITY. THE SPHERICITY TOLERANCE AND MEASUREMENTS WERE FOUND TO BE CONFORMING TO THE PRINT SPECIFICATIONS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT REGARDING THIS TYPE OF EVENT 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

    IT WAS REPORTED PATIENT'S RIGHT HIP WAS REVISED APPROXIMATELY 11 YEARS POST-IMPLANTATION DUE TO HIP AND PELVIC PAIN, TENDERNESS, PELVIC ABSCESSES, ASPIRATION OF PURULENT FLUID, GRINDING, AND ELEVATED METAL ION LEVELS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. REVISION OPERATIVE REPORT INDICATES MURKY FLUID WITHIN THE JOINT. THE HEAD AND LINER WERE REMOVED AND REPLACED AND A POLYETHYLENE BEARING WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY 11 YEARS POST-IMPLANTATION DUE TO HIP AND PELVIC PAIN, TENDERNESS, PELVIC ABSCESSES, ASPIRATION OF PURULENT FLUID, GRINDING, AND ELEVATED METAL ION LEVELS. REVISION OPERATIVE REPORT INDICATE MURKY FLUID WITHIN THE JOINT. THE HEAD AND LINER WERE REMOVED AND REPLACED AND A POLYETHYLENE BEARING WAS IMPLANTED.

    Description of Event or Problem · 1

    A REVISION PROCEDURE HAS BEEN INDICATED DUE TO AN UNKNOWN REASON; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790197 M2A MODULAR HEAD COMPONENT 38MM HEAD DIAMETER STANDARD NECK KWA BIOMET ORTHOPEDICS N/A 261190

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| O| R