BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS SIZE 16.25

    MDR report key: 17875535 · Received October 5, 2023

    Report

    Report Number
    0001822565-2023-02685
    Event Type
    Injury
    Date Received
    October 5, 2023
    Date of Event
    September 7, 2023
    Report Date
    January 19, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024132689
    PMA / PMN Number
    K182678
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 00877503602, LOT# 3141157, BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14; CAT# 00620205822, LOT# 65712881, SHELL POROUS WITH CLUSTER HOLES 58 MM; CAT# 00625006525, LOT# J7459469, BONE SCR 6.5X25 SELF-TAP; CAT# 00625006530, LOT# 65915092, BONE SCR 6.5X30 SELF-TAP; CAT# 00630505836, LOT# 65578308, LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 58 MM O.D. SHELL. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2023-02683. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS DISCARDED. 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} IT WAS REPORTED PATIENT WAS RIDING A BIKE AND HAD A FALL FROM THE BIKE CAUSING THE PERIPROSTHETIC FRACTURE. THE COMPONENTS ARE NOT RELATED TO CAUSE OF THE FALL. A PERIPROSTHETIC FRACTURE IS A BREAK IN THE BONE NEAR OR AROUND THE SITE OF AN IMPLANT. DURING THE JOINT REPLACEMENT SURGERY, A SERIES OF EVENTS OCCUR WHICH COMPROMISES THE INTEGRITY OF THE LONG BONES AROUND THE JOINT WHICH INCLUDE REAMING, RASPING, IRRIGATING, IMPACTING, AND DRILLING. THE IMPLANT IS THEN INSERTED AND SECURED INTO THESE BONES EITHER BY CEMENT, PRESS-FIT FORCE, OR BONE MATRIX INTEGRATION WHICH CAN TAKE VARYING AMOUNTS OF TIME TO BECOME SECURE IN THE BONE. AS THE BONE IS HEALING, IT IS MORE SUSCEPTIBLE TO DAMAGE AND FRACTURE FROM EXTERNAL TRAUMA SUCH AS A HIT, FALL, OR WEIGHT-BEARING FORCES. AS THE COMPLAINT INDICATES THE PATIENT EXPERIENCED A PERIPROSTHETIC FRACTURE, IT CAN BE EXPECTED THE PATIENT WOULD REQUIRE ADDITIONAL MEDICAL AND/OR SURGICAL INTERVENTION. 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 BY THE SURGEON THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE AND WAS REVISED APPROXIMATELY THREE MONTHS LATER DUE TO A FALL AND SUBSEQUENT PERIPROSTHETIC FEMUR FRACTURE. THERE WERE NO REPORTED SURGERY COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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
    2277112 MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS SIZE 16.25 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 65309738 00889024132689

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H