BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 DUAL MOBILITY LINER 50MM H

    MDR report key: 12627889 · Received October 13, 2021

    Report

    Report Number
    0001825034-2021-02852
    Event Type
    Injury
    Date Received
    October 13, 2021
    Date of Event
    September 20, 2021
    Report Date
    December 7, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K150522
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE LINER DID NOT CONTRIBUTE TO THE REPORTED EVENT AND THEREFORE WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 5 DAYS POST IMPLANTATION DUE TO INSTABILITY AND DISLOCATION. DURING THE REVISION THE ACETABULAR SHELL WAS IN A DIFFERENT POSITION FROM PREVIOUS SURGERY. THE SHELL, LINER, BEARING, SLEEVE, AND HEAD WERE EXCHANGED WITHOUT COMPLICATIONS. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE LINER DID NOT CONTRIBUTE TO THE REPORTED EVENT AND THEREFORE WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG#: 110010250 G7 OSSEOTI 4 HOLE SHELL 64MM H LOT#: 6459948. CATALOG#: 110031015 VIVACIT-E DM BEARING 28X50MM LOT#: 64731446. CATALOG#: 650-1068 CER OPTION TYPE 1 TPR SLEVE +6 LOT#: 2900905. CATALOG#: 650-1055 CER BIOLOXD OPTION HD 28MM LOT#: 3050674. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, PER HOSPITAL POLICY; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. 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: 0001825034-2021-02853, 0001822565-2021-02978.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO INSTABILITY AND DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1521936 G7 DUAL MOBILITY LINER 50MM H PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 755990

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R SEE H10 NARRATIVE