BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LINER

    MDR report key: 9459574 · Received December 12, 2019

    Report

    Report Number
    0001825034-2019-05555
    Event Type
    Injury
    Date Received
    December 12, 2019
    Date of Event
    July 10, 2019
    Report Date
    December 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #00877502802 BIOLOX® DELTA, CERAMIC FEMORAL HEAD LOT #2971426, ITEM #110010242 G7 OSSEOTI 3 HOLE SHELL LOT #6398821, ITEM #EP-200144G7 ACT ARTIC E1 HIP BRG 28X38MM LOT #274690, ITEM #UNKNOWN STEM LOT #UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2019 - 03424, 0001825034 - 2019 - 03471. COMPLAINT SAMPLE (SHELL AND BEARING) WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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 A PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY FIVE MONTHS POST OP, THE PATIENT WAS REVISED DUE TO DISLOCATION. IT WAS ALSO REPORTED THAT THE PATIENT HAD DISLOCATED THREE TIMES BEFORE THE REVISION SURGERY AND RELOCATION WAS PERFORMED EACH TIME. DURING THE REVISION PROCEDURE, IT WAS NOTED THAT THE BIOLOX HEAD HAD DISASSOCIATED FROM THE LINER AND THE LINER WAS LODGED POSTERIORLY OUTSIDE OF THE CUP. THE HEAD, LINER AND CUP WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255380 UNKNOWN LINER PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R