BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCR SELF-TAP

    MDR report key: 9899957 · Received March 30, 2020

    Report

    Report Number
    0001825034-2020-01323
    Event Type
    Injury
    Date Received
    March 30, 2020
    Report Date
    April 17, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K934765
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. THIS EVENT WILL BE REPORTED UNDER THE CORRECT MFR NUMBER - 2648920.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. THIS EVENT WILL BE REPORTED UNDER THE CORRECT MFR NUMBER - 2648920.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE DEVICE REMAINS IMPLANTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: PART # 010000856/ LINER / LOT #6475495, PART # 51-104110/ STEM / LOT #6479649, PART #110017102/ SHELL / LOT #6428483, PART # 650-1057/BIOLOX HEAD/ LOT #2958839, PART # 650-1065/TRP SLEVE / LOT #2950541. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2020 -01320, 0001825034 -2020 -01321, 0001825034 -2020 -01322.

    Description of Event or Problem · 1

    IT WAS REPORTED 3 MONTHS POST IMPLANTATION PATIENT IS ALLEGEDLY EXPERIENCING HIVES, BURNING, SWELLING AND PAIN INTO THE THIGH. RIGHT HIP REMAINS IMPLANTED. THE PATIENT IS GOING TO HAVE A METAL ALLERGY TEST CONDUCTED; HOWEVER, NO RESULTS HAVE BEEN PROVIDED TO DATE. 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
    364801 BONE SCR SELF-TAP PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. NI 64356267

    Patients

    Seq Age Sex Outcome Treatment
    1 Other