BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS POLY LOCK PIN

    MDR report key: 7433668 · Received April 16, 2018

    Report

    Report Number
    0001825034-2018-02800
    Event Type
    Injury
    Date Received
    April 16, 2018
    Report Date
    May 15, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    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: 163662, 28MM MOD HD STD NECK TP1 TAPER, 494560, 150476, OSS POLY TIBIAL BUSHING, 594960, 11-165218, RINGLOC BI-POLAR 28X47MM, 382420, 161034, OSS RS POLY FEM BUSHINGS SET/2, 252670, 150410, OSS TIBIAL POLY BEARING 12MM, 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 - 02797, 0001825034 - 2018 - 02801, 0001825034 - 2018 - 02802. REMAINS IMPLANTED.

    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
    276122 OSS POLY LOCK PIN PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 610340

    Patients

    Seq Age Sex Outcome Treatment
    1 Other