BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM MOD HD STD NECK TP1 TAPER

    MDR report key: 7433653 · Received April 16, 2018

    Report

    Report Number
    0001825034-2018-02798
    Event Type
    Injury
    Date Received
    April 16, 2018
    Report Date
    May 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4) CONCOMITANT MEDICAL PRODUCTS: 11-165218, RINGLOC BI-POLAR 28 X 47 MM, 382420. 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: 0001825034-2018-02797, 0001825034-2018-02799, 0001825034-2018-02800, 0001825034-2018-02801, 0001825034-2018-02802. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    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
    275864 28MM MOD HD STD NECK TP1 TAPER PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 494560

    Patients

    Seq Age Sex Outcome Treatment
    1 Other