BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIV 2-HOLE SHL 50MM LNR SZ 23

    MDR report key: 7265949 · Received February 13, 2018

    Report

    Report Number
    0001825034-2018-00870
    Event Type
    Malfunction
    Date Received
    February 13, 2018
    Date of Event
    January 12, 2018
    Report Date
    November 15, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK092130
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS DETERMINED THIS REPORTING IS A DUPLICATE OF 0001825034-2018-00709. PLEASE VOID THIS SUBMISSION.

    Description of Event or Problem · 0

    IT WAS DETERMINED THIS REPORTING IS A DUPLICATE OF 0001825034-2018-00709. PLEASE VOID THIS SUBMISSION..

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT: XL-053250, RLOC-X ARCOMXL H/W 50/32MM 23, 6055481. (B)(6). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 00887.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANTING THE LINER AND STEM THE TRIAL FEMORAL HEAD WAS PUT IN. HOWEVER, WHEN TAKING OUT THE TRIAL FEMORAL HEAD, THE LINER CAME OUT TOGETHER WITH THE HEAD. THEN, THE SURGEON TRIED TO IMPLANT THE LINER INTO THE CUP AGAIN, BUT IT WOULD NOT STABILIZE. FINALLY, THE SURGEON HAD TO TAKE OUT THE CUP AND IMPLANT ANOTHER CUP TO COMPLETE THE SURGERY. THE SURGERY WAS DELAYED FOR 30 MINUTES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111967 UNIV 2-HOLE SHL 50MM LNR SZ 23 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 959740

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention