BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 ACETABULAR LINER 10 DEG E1 LINER 36MM E

    MDR report key: 20047108 · Received August 23, 2024

    Report

    Report Number
    0001825034-2024-02065
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    August 15, 2024
    Report Date
    October 11, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304526761
    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

    (B)(4). D10: CAT# 00811400218 LOT# 65521424 FEMORAL STEM 12/14 NECK TAPER STD. OFFSET SIZE 2 180 MM STEM LENGTH CAT# 010000703 LOT# 7453541 G7 BONEMASTER LTD ACET SHL 52E CAT# 802203603 LOT# 3010487 FEMORAL HEAD 12/14 TAPER 36 MM DIAMETER +3.5 MM NECK LENGTH G2: FOREIGN: AUSTRALIA THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS NOT RETURNED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED ONE IMAGE WAS PROVIDED WHICH SHOWS THE HEAD AND LINER REMOVED AND ON THE TABLE WITH THE PATIENT BIO ON IT. NO OTHER INFORMATION COULD BE OBTAINED FROM THE IMAGE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: IMPLANT FIT IS MAINTAINED. THERE IS MALALIGNMENT SECONDARY TO THE ARTHROPLASTY DISLOCATION. BONE QUALITY IS OSTEOPENIC. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 1 YEAR LATER DUE TO DISLOCATION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2072222 G7 ACETABULAR LINER 10 DEG E1 LINER 36MM E PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6848098 00880304526761

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11 NARRATIVE