BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR FMRL 15X150

    MDR report key: 9706659 · Received February 13, 2020

    Report

    Report Number
    0001825034-2020-00650
    Event Type
    Injury
    Date Received
    February 13, 2020
    Date of Event
    December 28, 2014
    Report Date
    May 18, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS REPORT NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER REPORT NUMBER 0001825034-2020-00106.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS REPORT NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER REPORT NUMBER 0001825034-2020-00106.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: M2A-MAGNUM MOD HD SZ 52MM, PN 157452, LN 101240. M2A-MAGNUM 52-60MM TPR INSRT-3, PN 139266, LN 068770. M2A-MAGNUM PF CUP 58ODX52ID, PN US157858, LN 722540. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-00101-1, 0001825034-2020-00102-1, 0001825034-2020-00103-1. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN.  THE INVESTIGATION IS IN PROCESS.  ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PRIMARY RIGHT THA PERFORMED. PATIENT SUBSEQUENTLY DEVELOPED ELEVATED METAL IONS AND NOISE. ATTEMPTED REVISION PROCEDURE OCCURRED 9 YEARS LATER, AND UNABLE TO DISENGAGE FEMORAL HEAD, SURGICAL PROCEDURE WAS ABORTED AND SURGICAL SITE WAS IRRIGATED AND CLOSED. APPROXIMATELY 1 WEEK POST ABORTED PROCEDURE, PATIENT DEVELOPED FEVER AND SUPERFICIAL SURGICAL SITE INFECTION. I&D OF SURGICAL SITE PERFORMED 9 DAYS LATER, NO COMPONENTS REMOVED. PATIENT RECEIVED IV ANTIBIOTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172159 TAPERLOC POR FMRL 15X150 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 301550

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R