BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI ACETABULAR SHELL

    MDR report key: 21717888 · Received March 28, 2025

    Report

    Report Number
    0001825034-2025-00862
    Event Type
    Injury
    Date Received
    March 28, 2025
    Report Date
    April 11, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K140669
    Adverse Event
    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

    UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS PRODUCT WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT SHOULD BE VOIDED.

    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

    UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS PRODUCT WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT SHOULD BE VOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471283 G7 OSSEOTI ACETABULAR SHELL PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 6463667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male SEE H11 NARRATIVE.