BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 HI-WALL E1 LINER 36MM D

    MDR report key: 20567772 · Received October 30, 2024

    Report

    Report Number
    0001825034-2024-02553
    Event Type
    Injury
    Date Received
    October 30, 2024
    Date of Event
    October 17, 2024
    Report Date
    February 3, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304527096
    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 UPDATED: B4;G3;H2;H3;H6 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT CANNOT BE CONFIRMED. 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: CAT# 110010243 LOT# G7 OSSEOTI 3 HOLE SHELL 50MM D. CAT# 00-6250-065-30 LOT# J7356061 TRILOGY BONE SCR 6.5X30. CAT# 01.06010.108 LOT# 3151673 AVENIR MULLER STEM 8 LATERAL. CAT# 802203602 LOT# 2994091 ZB 12/14 COCR HD 36MM X +0. G2: FOREIGN: COUNTRY: AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 11 MONTHS POST IMPLANTATION OF A RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO FOUR DISLOCATIONS WHICH OCCURRED ON UNSPECIFIED DATES. THE DISLOCATIONS WERE NOT RELATED TO FALLS. IT WAS REPORTED THAT THE PATIENT ARRIVED FOR THE REVISION SURGERY WALKING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711450 G7 HI-WALL E1 LINER 36MM D PROTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 7339289 00880304527096

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H