BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SIZE 58MM

    MDR report key: 7467798 · Received April 27, 2018

    Report

    Report Number
    0001825034-2018-02587
    Event Type
    Injury
    Date Received
    April 27, 2018
    Date of Event
    March 29, 2018
    Report Date
    April 27, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS DEVICE LOCATION IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: ITEM# 11-173662 M2A 38MM MODULAR HEAD STANDARD NECK LOT# 532000, X11-180315 BI-METRIC/X POROUS NECK LAT 15X155 LOT# 333810. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2018 -02585. 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. 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 THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY REVISION APPROXIMATELY THIRTEEN (13) YEARS POST-IMPLANTATION DUE TO ELEVATED ION LEVELS AND CHRONIC HIP PAIN. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313007 M2A-38 CUP NON FLARED SIZE 58MM HIP PROSTHESIS KWA ZIMMER BIOMET, INC. 570050

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R