BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC BI-POLAR 28X47MM

    MDR report key: 7433652 · Received April 16, 2018

    Report

    Report Number
    0001825034-2018-02797
    Event Type
    Injury
    Date Received
    April 16, 2018
    Report Date
    May 15, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    PK833175
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CONCOMITANT MEDICAL PRODUCTS: 163662, 28 MM MOD HD STD NECK TP1 TAPER, 494560. THE 150476, OSS POLY TIBIAL BUSHING, 594960. THE 150478, OSS POLY LOCK PIN, 610340. THE 161034, OSS RS POLY FEM BUSHINGS SET/2, 252670. THE 150410, OSS TIBIAL POLY BEARING 12 MM, 837020. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-02798, 0001825034-2018-02799, 0001825034-2018-02800, 0001825034-2018-02801, 0001825034-2018-02802. REMAINS IMPLANTED

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES 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 PATIENT IS EXPERIENCING NICKEL ALLERGY THREE YEARS POST-IMPLANTATION. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275863 RINGLOC BI-POLAR 28X47MM PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 382420

    Patients

    Seq Age Sex Outcome Treatment
    1 Other