BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SCREW

    MDR report key: 18085057 · Received November 7, 2023

    Report

    Report Number
    0001825034-2023-02626
    Event Type
    Malfunction
    Date Received
    November 7, 2023
    Date of Event
    October 11, 2023
    Report Date
    December 1, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THERE WAS NO DEVICE PROBLEM FOUND. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 010000925 G7 HI-WALL E1 LINER 32MM C 7485855 , 010000661 G7 PPS LTD ACET SHELL 48C 7384811, UNKNOWN SCREW UNKNOWN, UNKNOWN SCREW UNKNOWN. G2: FOREIGN: CHINA MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-02609, 0001825034-2023-02610 , 0001825034-2023-02625, 0001825034 - 2023 - 02627. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER IMPLANTING THE G7 48MMC ACETABULAR CUP INTO THE PATIENT'S BODY, THE SURGEON FOUND THAT THE SCREW HOLES HAD SLIPPED, AND THE PLUG COULD NOT BE FIRMLY SCREWED IN CAUSING THE SCREWS TO GO THROUGH THE SHELL. THE CORRESPONDING E1 32MM SIZEC ACETABULAR LINER WAS THEN INSERTED INTO THE ACETABULUM, AND IT WAS FOUND THAT THE ACETABULAR LINER COULD BE FLUSHED WITH THE EDGE OF THE ACETABULAR CUP, BUT IT DID NOT LOCK INTO PLACE. WHEN TESTED WITH VASCULAR FORCEPS, THE ACETABULAR LINER WAS ABLE TO BE REMOVED WITH A SINGLE PINCH. THE DOCTOR FINALLY REMOVED THE 48MM ACETABULAR CUP AND REPLACED IT WITH A 50MM ACETABULUM AND THE CORRESPONDING LINER WHICH FIT SECURELY CAUSING A TWENTY-MINUTE DELAY OF PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339855 UNKNOWN SCREW PROTHESIS, HIPS LPH ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female SEE H10 NARRATIVE