BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY HEAD SHELL WITH PLUG

    MDR report key: 7770490 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-08019
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    February 12, 2014
    Report Date
    October 16, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK861114
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPLANTS WERE NOT EXPLANTED. WRONG DATE WAS REPORTED IN THE INITIAL MEDWATCH. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OP NOTES. REVIEW OF THE OP NOTES STATES THAT DURING THE PROCEDURE SURGEON NOTED THAT THERE WAS CONSIDERABLE AMOUNT OF LOOSE PERMANENT SUTURE THAT WAS DIRECTLY UNDER THE ILIOTIBIAL BAND WHERE THE PATIENT HAD BEEN REPORTING PAIN. ALL SUTURE WAS REMOVED, AND THEN PROCEEDED TO DEBRIDEMENT OF EXTENSIVE BURSITIS UNDER THE ILIOTIBIAL BAND. ILIOTIBIAL RELEASE WAS PERFORMED AS WELL. SURGEON CONFIRMED NO FURTHER LOOSE SUTURES OR ADDUCTORS WERE INTACT. NO COMPLICATIONS NOTED DURING THE PROCEDURE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 15-103205, TAPERLOC MICRO FEMORAL, LOT # 402250; CATALOG #: 11-363660, MODULAR HEAD TYPE 1 TAPER, LOT # 505940; CATALOG #: EP-105914, E-POLY RINGLOC ACETABULAR LINER, LOT # 974060. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-08017, 08018, 08019, 08020. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY TOTAL KNEE ARTHROPLASTY APPROXIMATELY 10 YEARS AGO. SUBSEQUENTLY, THE PATIENT HAD BILATERAL THA FOR HIV-ASSOCIATED AVN AND DEVELOPED CHRONIC BILATERAL TROCHANTERIC BURSITIS. THE PATIENT UNDERWENT LEFT GREATER TROCHANTERIC BURSECTOMY AND ILIOTIBIAL RELEASE APPROXIMATELY 4 YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610002 MALLORY HEAD SHELL WITH PLUG PROSTHESIS HIP JDI ZIMMER BIOMET, INC. N/A 569300

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other