BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 1 PC SHELL 38MMX58MM

    MDR report key: 6926762 · Received October 7, 2017

    Report

    Report Number
    0001825034-2015-02115
    Event Type
    Injury
    Date Received
    October 7, 2017
    Date of Event
    May 5, 2015
    Report Date
    November 28, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    Additional Manufacturer Narrative · 1

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2015-02115, 0001825034-2015-02114, 0001825034-2017-08157. CONCOMITANT MEDICAL PRODUCTS: M2A 38MM MOD HD +3MM NK CATALOG# 11-173663 LOT 964290, M2A 1 PC SHELL 38MMX58MM CATALOG# 15-105058 LOT# 570270, UNKNOWN HIP SCREW. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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

    ADDITIONAL MEDICAL RECORDS RECEIVED STATED, LAB WORK PRIOR TO THE REVISION SHOWED ELEVATED ION LEVELS. DURING THE REVISION IT A BROWNISH FLUID WAS ENCOUNTERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL LEFT HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2015 DUE TO PATIENT ALLEGATIONS OF PAIN AND INSTABILITY. DURING THE PROCEDURE, IT WAS NOTED THAT A RIM SCREW WAS FRACTURED, BUT IT IS UNKNOWN IF IT BROKE DURING OR PRIOR TO REMOVAL. THE RIM SCREW DID NOT CAUSE ANY ISSUES. PATIENT WAS REVISED TO A COMPETITOR CUP AND BIOMET HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706102 M2A 1 PC SHELL 38MMX58MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS 570270

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R