BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL E1 LINER 36MM F

    MDR report key: 18844687 · Received March 6, 2024

    Report

    Report Number
    0001825034-2024-00577
    Event Type
    Injury
    Date Received
    March 6, 2024
    Date of Event
    February 13, 2024
    Report Date
    June 27, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304526433
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 650-0662 LOT# 3340521 DELTA CERAMIC FEM HD 36/+3MM CAT# 010000704 LOT# 3578463 G7 BONEMASTER LTD ACET SHL 54F CAT# 51-199341 LOT# 882080 SIRIUS HIP STEM 44-D CAT# 51-199300 LOT# UNK SIRIUS WINGED CENTRALIZER G2: FOREIGN: UNITED KINGDOM THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. 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. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED}. THIS EVENT IS FOR A PATIENT WHO TRIPPED WHILE PLAYING WITH THEIR DOG, TWISTED AND FELL, CAUSING A DISLOCATION. AS THE COMPLAINT INDICATES, THE PATIENT SUSTAINED AN EXTERNAL TRAUMA THAT CAUSED THE COMPLICATION WITH NO ALLEGATIONS AGAINST THE DEVICE PRIOR TO THE EVENT. 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 THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY APPROXIMATELY 8 YEARS LATER FOLLOWING A FALL. THE PATIENT DISLOCATED THEIR RIGHT HIP RESULTING IN A CLOSED REDUCTION. IT WAS REPORTED THAT NO FURTHER DETAILS ARE 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
    119472 G7 NEUTRAL E1 LINER 36MM F PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 3559351 00880304526433

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H10 NARRATIVE