BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER

    MDR report key: 8743858 · Received June 28, 2019

    Report

    Report Number
    0001822565-2019-02720
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    May 3, 2019
    Report Date
    June 27, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K161830
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER :00-8018-032-02 LOT NUMBER :62199426 BRAND NAME: FEMORAL HEAD, CATALOG NUMBER :00-6202-054-22 LOT NUMBER : 62178505 BRAND NAME: ACETABULAR SHELL, CATALOG NUMBER: 00-6310-050-32 LOT NUMBER : 62202335 BRAND NAME: XLPE LINER, CATALOG NUMBER: 00-6250-065-30 LOT NUMBER :62205046 BRAND NAME: TRILOGY SCREW. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THAT THE PATIENT HAD A LEFT HIP MILD PARTIAL TEAR OF THE GLUTEUS MEDIAS TENDON INVOLVING THE ANTEROLATERAL MOST FIBERS.NO OTHER ISSUES WERE NOTED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. DEVICE HISTORY RECORD 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 · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AND TENDON TEAR APPROXIMATELY 7 YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537966 FEMORAL STEM 12/14 NECK TAPER PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 62141481

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O