BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 ACETABULAR SYSTEM SHELL 52E

    MDR report key: 19483130 · Received June 7, 2024

    Report

    Report Number
    0001825034-2024-01513
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    May 9, 2024
    Report Date
    November 6, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304524224
    PMA / PMN Number
    K121874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: UNK SHELL; CAT# 110003634 LOT# 3140953 BIOLOX DELTA CER LNR 36MM E, G2: FOREIGN ¿ CHINA. THE 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D9; G3; H2; H3; H6; H10. VISUAL EXAMINATION OF THE RETURNED PRODUCT/PROVIDED PICTURES IDENTIFIED LINERS LOT 7252613 AND 7264159, AND SHELL LOT 7659826. SHELL: BIO DEBRIS IS EMBEDDED IN THE POROUS SURFACE AND IN THE ANTI ROTATION SCALLOPS. SCRATCHES ARE NOTED ON THE INNER SPHERICAL SURFACE. APICAL HOLE THREAD SHOWS GALLING AND DEFORMATION FROM USE. APICAL HOLE PLUG AND SCREW HOLE PLUGS WERE NOT RETURNED WITH THE DEVICE FOR REVIEW. NO OTHER DAMAGE WAS NOTED. SHELL WAS DIMENSIONALLY INSPECTED AT F71 OVERALL WIDTH ON THE PRINT AND FOUND TO BE IN SPECIFICATION. DHR SHOWS SHELL TO BE 100% CMM INSPECTED DURING MANUFACTURING. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. UNABLE TO CONFIRM COMPLAINT. 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 THAT DURING AN INITIAL HIP PROCEDURE, THE POLYETHYLENE LINER WAS UNABLE TO BE IMPLANTED INTO THE CUP. REPEATED ATTEMPTS TO IMPLANT THE LINER AT THE CORRECT ANGLE CONTINUED TO FAIL. THE CORRESPONDING CERAMIC LINER WAS THEN USED AND COULD NOT BE IMPLANTED. THE FIRST CUP WAS REMOVED AND A SECOND, LARGER CUP WAS INSTALLED. THE SURGEON ATTEMPTED TO IMPLANT THE POLYETHYLENE LINER AND WAS UNSUCCESSFUL. THE CORRESPONDING CERAMIC LINER WAS ABLE TO BE SUCCESSFULLY IMPLANTED INTO THE SECOND CUP TO COMPLETE THE PROCEDURE. THERE WAS A 25 MINUTE SURGICAL DELAY. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258391 G7 ACETABULAR SYSTEM SHELL 52E PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 7659826 00880304524224

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female