BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI MULTIHOLE 46MM B

    MDR report key: 18284768 · Received December 7, 2023

    Report

    Report Number
    0001825034-2023-02903
    Event Type
    Injury
    Date Received
    December 7, 2023
    Date of Event
    October 19, 2023
    Report Date
    March 13, 2024
    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
    JA
    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 VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE EXPLANTED SHELL AND SCREWS, WITH ONE SCREW FRACTURED. NO FURTHER EVALUATION CAN BE MADE FROM THE PROVIDED PICTURES. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. 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: 010000980; ITEM NAME: G7 FREEDOM CONST E1 LNR 32MM B LOT # 6918291; 802403203; ITEM NAME: CONSTRAINED HEAD 12/14 TAPER 32 MM DIAMETER +3 MM NECK; LENGTH FOR USE WITH FREEDOM CONSTRAINED LINERS LOT # 3001444; 00-6250-065-20; ITEM NAME: TRILOGY BONE SCR 6.5X20 LOT # J7054522; 00-6250-065-25; ITEM NAME: TRILOGY BONE SCR 6.5X25 LOT # J7167566; 00-6250-065-25; ITEM NAME: TRILOGY BONE SCR 6.5X25 LOT # J7211462. G2: FOREIGN: JAPAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED H3 OTHER TEXT : DEVICE LOCATION IS UNKNOWN.

    Description of Event or Problem · 0

    THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 1 YEAR AND 2 MONTHS POST IMPLANTATION DUE TO CUP LOOSENING. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128749 G7 OSSEOTI MULTIHOLE 46MM B PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 7075146

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention| H PLEASE SEE H10