BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER

    MDR report key: 7344416 · Received March 16, 2018

    Report

    Report Number
    0001822565-2018-01240
    Event Type
    Injury
    Date Received
    March 16, 2018
    Date of Event
    February 15, 2018
    Report Date
    June 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK032726
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00877503602, BIOLOX® DELTA CERAMIC FEMORAL HEAD, 2850527, UNKNOWN, UNKNOWN CUP, UNKNOWN, UNKNOWN, UNKNOWN LINER, UNKNOWN. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED AS NO X-RAY OR OPERATIVE NOTES WERE AVAILABLE. THE DEVICE WAS RETURNED FOR EVALUATION. THE STEM IS CONFORMING TO THE OVERLAY. DEVICE WAS CONFORMING WHEN IT LEFT ZIMMER BIOMET. DEVICE HISTORY RECORD (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 THAT THE PATIENT HAD A REVISION PROCEDURE APPROXIMATELY ONE YEAR POST IMPLANTATION DUE TO STEM FAILURE, PAIN, AND LOOSENING. IT WAS REPORTED THE FEMORAL STEM HAD FAILED TO IN GROW. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187733 FEMORAL STEM 12/14 NECK TAPER PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 63514681

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R