BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 DUAL MOBILITY ACETABULAR SYSTEM

    MDR report key: 21717893 · Received March 28, 2025

    Report

    Report Number
    0001825034-2025-00863
    Event Type
    Injury
    Date Received
    March 28, 2025
    Date of Event
    March 10, 2025
    Report Date
    June 23, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304703537
    PMA / PMN Number
    K150522
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT: 12-115111, LOT: 2965002, CER BIOLOXD MOD HD 28MM +3 NK, CAT: 00625006530, LOT: 64378436, BONE SCR 6.5X30 SELF-TAP, CAT: 00625006535, LOT: 64383906, BONE SCR 6.5X35 SELF-TAP, CAT: 00625006540, LOT: 64172354, BONE SCR 6.5X40 SELF-TAP, CAT: 192011, LOT: 441380, ECHO POR FMRL NC 11X135MM. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. 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: B1; B2; B3; B5; D6B; G3; H2; H6. THE INVESTIGATION IS IN PROCESS. 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: D4; G3; H2; H3; H4; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT CANNOT BE CONFIRMED. 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 APPROXIMATELY FIVE YEARS POST-IMPLANTATION, THE PATIENT WILL BE REVISED DUE TO UNKNOWN REASONS. IT IS UNKNOWN IF A REVISION HAS TAKEN PLACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY FIVE YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO DISLOCATION. A NEW LINER AND HEAD WERE IMPLANTED. 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
    1471288 G7 DUAL MOBILITY ACETABULAR SYSTEM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 665360 00880304703537

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| O| R SEE H11 NARRATIVE