BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 OSSEOTI 3 HOLE SHELL 50MM D

    MDR report key: 15408983 · Received September 13, 2022

    Report

    Report Number
    0001825034-2022-02116
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    August 30, 2022
    Report Date
    March 30, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    0088788355875
    PMA / PMN Number
    K140669
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CMP-(B)(4). FOREIGN: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034-2022-02114 0001825034-2022-02115.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. ONE G7 BALL HEX DRVR FOR INSR HNDL ITEM# 010002736 LOT# ZB7037336, ONE G7 STR MODULAR SHELL INSERTER ITEM# 110003451 LOT# 541700, AND ONE G7 OSSEOTI 3 HOLE SHELL 50MM D ITEM# 110010243 LOT#7240122 WERE RETURNED AND EVALUATED. UPON VISUAL INSPECTION THERE IS SCUFFING ON THE DRIVER HANDLE ALONG WITH WEAR LINES. THE TIP OF THE DEVICE HAD FRACTURED. THE INSERTER SHOWED INDENTATION NEAR THE RUBBER HANDLE AND TO THE STRIKE PLATE. THE INSERTER IS STUCK INSIDE OF THE SHELL AND COULD NOT BE REMOVED. THE SHELL HAD NO VISIBLE DAMAGE. THE THREADS OF THE SHELL AND INSERTER COULD NOT BE CHECKED DUE TO NOT BEING ABLE TO SEPARATE THEM. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.THE FOLLOWING SECTIONS WERE UPDATED/CORRECTEDUPDATED: B4, B5, G3, G6, H2, H3, H6, H10.VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE SHELL REMAINS ASSEMBLED WITH THE INSERTER. THE TIP OF THE HEX DRIVER IS FRACTURED.DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER IMPLANTATION AND WHEN LOOSENING THE SOCKET, THE BALL HEX DRIVER BROKE OFF. THE SHELL COULD NO LONGER BE DETACHED AFTER REPEATED ATTEMPTS FROM THE INSERT HANDLE AND HAD TO BE REMOVED TOGETHER WITH THE PAN. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2392474 G7 OSSEOTI 3 HOLE SHELL 50MM D PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 7240122 0088788355875

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CAT#: 010002736 HEX DRIVER LOT#: ZB7037336.| CAT#: 110003451 G7 INSERTER LOT#: NI.