BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 HI-WALL E1 LINER 36MM F

    MDR report key: 19531645 · Received June 13, 2024

    Report

    Report Number
    0001825034-2024-01590
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    September 26, 2023
    Report Date
    October 16, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304527119
    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; HOWEVER, A PICTURE WAS PROVIDED. A VISUAL EXAMINATION OF THE PROVIDED PICTURE IDENTIFIED THAT THE HEAD WAS STILL WITHIN THE LINER; NO OTHER INFORMATION CAN BE OBTAINED FROM THE IMAGE. A 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 REPORTED ISSUE COULD NOT 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). G2: FOREIGN: COUNTRY: AUSTRALIA D10: CAT# 802203602 LOT# 3153669 FEMORAL HEAD 12/14 TAPER 36 MM DIAMETER +0 MM NECK LENGTH 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 3 MONTHS POST IMPLANTATION OF A RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT HAD A FALL WHICH RESULTED IN A RIGHT SIDED DISLOCATED HIP. SUBSEQUENTLY, THE PATIENT WAS REVISED AND THE HEAD AND LINER WERE EXCHANGED. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184553 G7 HI-WALL E1 LINER 36MM F PROTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 7570757 00880304527119

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R