BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER

    MDR report key: 11230601 · Received January 26, 2021

    Report

    Report Number
    0002648920-2021-00015
    Event Type
    Injury
    Date Received
    January 26, 2021
    Date of Event
    January 4, 2021
    Report Date
    May 12, 2021
    Manufacturer
    .
    Product Code
    JDI
    UDI-DI
    00889024145825
    PMA / PMN Number
    K191735
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT HAS BEEN RETAINED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL DEVICES: ITEM # 00877503602/ BIOLOX® DELTA, CERAMIC FEMORAL HEAD/ LOT # 2830674; ITEM# 00630505036/ LINER / LOT # 63092132; ITEM # UNKNOWN / UNKNOWN CUP/LOT # UNKNOWN. REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT HIP REVISION SURGERY APPROXIMATELY FOUR YEARS POST IMPLANTATION DUE TO PERI-PROSTHETIC FRACTURE AND FEMORAL LOOSENING. THE STEM, HEAD AND LINER WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126949 FEMORAL STEM 12/14 NECK TAPER PROSTHESIS HIP JDI . NI 63145223 00889024145825

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10