BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER

    MDR report key: 7244682 · Received February 6, 2018

    Report

    Report Number
    0001822565-2018-00729
    Event Type
    Injury
    Date Received
    February 6, 2018
    Date of Event
    August 25, 2015
    Report Date
    June 14, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 172805, SULOX¿¢ HEAD Sà 28/-3.5 TAPER 12/14, 2694526; 4244, ALLOFIT ALLOCLASSIC SHELL, 2700921; 0100013308, DURASUL® ALPHA INSERT HOODED HH/28, 2687025.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - THE EVENT OCCURRED IN (B)(6). 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. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PREVIOUSLY REPORTED INFECTION HAS NOT BEEN CONFIRMED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS AND MEDICAL RECORDS. 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. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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'S LEFT HIP WAS REVISED APPROXIMATELY TWO YEARS POST IMPLANTATION DUE TO LOOSENING. AN INTRAOPERATIVE LOW-GRADE INFECTION WITH STAPH CAPITIS WAS FOUND. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY 2 YEARS POST IMPLANTATION DUE TO ASEPTIC STEM LOOSENING. A BLACK COLORED EFFUSION INCLUDING METALLIC PARTICLES DRAINED OUT OF JOINT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87526 FEMORAL STEM 12/14 NECK TAPER PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 62282220

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R