BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MODULAR HEAD COMPNOENT 38MM HEAD DIAMETER STANDARD NECK

    MDR report key: 6638767 · Received June 13, 2017

    Report

    Report Number
    0001825034-2017-03936
    Event Type
    Injury
    Date Received
    June 13, 2017
    Date of Event
    June 19, 2014
    Report Date
    June 13, 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
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: M2A 38MM ACETABULAR CUP CATALOG#: RD118852 LOT#: 644660, BI-METRIC FEMORAL STEM CATALOG#: 162311 LOT#: 02063690. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR 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. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTRIBUTE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2016-03891, 0001825034-2017-03936.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY ELEVEN YEARS POST-IMPLANTATION DUE TO SQUEAKING, PAIN, DRY COUGH, RHONCHUS, AND ELEVATED METAL ION LEVELS. GREYISH METAL INFUSED TISSUE WAS FOUND DURING THE REVISION PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417987 M2A MODULAR HEAD COMPNOENT 38MM HEAD DIAMETER STANDARD NECK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 788450

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R