BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER

    MDR report key: 12894203 · Received November 30, 2021

    Report

    Report Number
    0001822565-2021-03354
    Event Type
    Injury
    Date Received
    November 30, 2021
    Date of Event
    October 12, 2021
    Report Date
    December 10, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024131842
    PMA / PMN Number
    K032726
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: H2; H3; H6. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS RECEIVED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED A RIGHT THA WAS PERFORMED. THE PATIENT BEGAN REPORTING PAIN AND DECLINING FUNCTION WITH LUCENCIES OBSERVED AROUND THE STEM. A REVISION WAS PERFORMED WHERE THE STEM WAS FOUND TO BE LOOSE. THE LINER, STEM, AND HEAD WERE EXPLANTED, AND ZIMMER PRODUCTS WERE PLACED. LIMB LENGTHS WERE RESTORED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL DEVICES: 110024464 729640 G7 DUAL MOBILITY LINER 44MM F; 110031012 65055299 VIVACIT-E DM BEARING 28X44MM; 650-1159 3073375 DELTA CER FEM HD 28/-3MM T1; 11-300814 820590 ARCOS 14X150MM SPL TPR DIST; 00877503602 3044108 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE DEVICE WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT WAS REVISED APPROXIMATELY 6 MONTHS POST IMPLANTATION DUE TO LOOSENING OF THE FEMORAL STEM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1794970 FEMORAL STEM 12/14 NECK TAPER PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64670372 00889024131842

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H