BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HI-WALL E1 LINER 32MM C

    MDR report key: 18072999 · Received November 6, 2023

    Report

    Report Number
    0001825034-2023-02610
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Date of Event
    October 11, 2023
    Report Date
    December 1, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304527010
    PMA / PMN Number
    K121874
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPDATED: G3, G6, H2, H3, H6 VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED NO DAMAGE TO THE SHELL. THE LINER HAS VISIBLE DAMAGE TO THE LOCKING FEATURE. ALL 4 SCREW PLUGS ARE INSTALLED. THE APICAL PLUG IS FULLY INSTALLED AND IS NOT SITTING PROUD. EVERY CORNER OF THE HEX FEATURE HAS DAMAGE TO IT AND ROLLED MATERIAL IS PRESENT. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. THIS COMPLAINT WAS CONFIRMED BASED ON THE DAMAGE ON BOTH THE DOME HOLE PLUG AND LINER FROM ATTEMPTED USE. 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

    (B)(4). D10: 010000661 G7 PPS LTD ACET SHELL 48C 7384811. G2: FOREIGN: CHINA. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-02609. 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.

    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. 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
    2139034 G7 HI-WALL E1 LINER 32MM C PROTHESIS, HIPS PBI ZIMMER BIOMET, INC. N/A 7485855 00880304527010

    Patients

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