BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI MULTIHOLE 74MM J

    MDR report key: 17584394 · Received August 21, 2023

    Report

    Report Number
    0001825034-2023-01958
    Event Type
    Injury
    Date Received
    August 21, 2023
    Report Date
    October 11, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K140669
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4 G3 G6 H2 H6 H10 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED FOR THE SHELL. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 110024468 G7 DUAL MOBILITY LINER 60MM J LOT# 512100; 110031020 ITEM NAME VIVACIT-E DM BEARING 28X60MM LOT # 64709980; 010000998 ITEM NAME G7 SCREW 6.5MM X 25MM LOT # 7453205; 010000998 ITEM NAME G7 SCREW 6.5MM X 25MM LOT # 6973105; 010000998 ITEM NAME G7 SCREW 6.5MM X 25MM LOT # 3920103; 010000996 ITEM NAME G7 SCREW 6.5MM X 15MM LOT # 7053137; 010000996 ITEM NAME G7 SCREW 6.5MM X 15MM LOT # 6825841; 010000997 ITEM NAME G7 SCREW 6.5MM X 20MM LOT # 7091303; 010000999 ITEM NAME G7 SCREW 6.5MM X 30MM LOT # 7438777; 010000998 ITEM NAME G7 SCREW 6.5MM X 25MM LOT # 7042299. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 01959. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT CURRENTLY REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTED: D4: LOT NUMBER UPDATED TO UNKNOWN AS LOT PREVIOUSLY PROVIDED IS INCORRECT.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WILL UNDERGO A REVISION IN THE FUTURE DUE TO SCREW FRACTURE AND CUP LOOSENING. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483553 G7 OSSEOTI MULTIHOLE 74MM J PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A R3674706A

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization| O