BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 BONEMASTER LTD ACET SHL 50D

    MDR report key: 19370929 · Received May 22, 2024

    Report

    Report Number
    0001825034-2024-01329
    Event Type
    Injury
    Date Received
    May 22, 2024
    Date of Event
    May 1, 2024
    Report Date
    August 23, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304524613
    PMA / PMN Number
    K121874
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 {UPDATE/CORRECTED}. UPDATED: D4; G3; H2; H3; H4; H6. D4: PROVIDED INFORMATION SUGGESTS THAT LOT NUMBER COULD BE 7216410 OR 7335542 FOR THE DEVICE WITH LOT NUMBER 7216410: MANUFACTURE DATE: AUG 3, 2022 (BRIDGEND, UK), EXPIRATION DATE: AUG 3, 2032, UDI: (B)(4). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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). D4: PROVIDED INFORMATION SUGGESTS THAT LOT NUMBER COULD BE 7216410 OR 7335542. D10: CAT #: 110024462, LOT #: 65693056, G7 DUAL MOBILITY LINER 40MM D. CAT #: 110024462, LOT #: 65698952, G7 DUAL MOBILITY LINER 40MM D. CAT #: EP-200146, LOT #: 65690347, ACT ARTIC E1 HIP BRG 28X40MM. CAT #: 650-1159, LOT #: 3111506, DELTA CER FEM HD 28/-3MM T1. G2: FOREIGN: AUSTRALIA 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.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 1 YEAR LATER DUE TO JOINT IMPINGEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704738 G7 BONEMASTER LTD ACET SHL 50D PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 7335542 00880304524613

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention| H