BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVENIR FEMORAL STEM CEMENTLESS COLLARED STANDARD OFFSET 12/14 TAPER SIZE 4

    MDR report key: 20363722 · Received October 3, 2024

    Report

    Report Number
    0001822565-2024-03178
    Event Type
    Injury
    Date Received
    October 3, 2024
    Date of Event
    December 15, 2023
    Report Date
    February 12, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00889024509030
    PMA / PMN Number
    K182048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: COUNTRY: UNITED KINGDOM H10: CAT# 00877503603 LOT# 3171535 BIOLOX® DELTA, CERAMIC FEMORAL HEAD CAT# 00875201236 LOT# 66125201 36MM I.D. SIZE KK ELEVATED RIM LINER CAT# 00875705601 LOT # 66044089 56MM O.D. CONTINUUM TRABECULAR METAL UNCEMENTED WITH CLUSTER HOLES SHELL. 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.

    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. H6: COMPONENT CODE: MECHANICAL (G04) - STEM. 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 RELATED TO THE REPORTED EVENT. REPORTED EVENT IS NOT RELATED TO A COMBINATION OF PRODUCTS; THEREFORE, A COMPATIBILITY REVIEW IS NOT APPLICABLE. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY APPROXIMATELY ELEVEN MONTHS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED ONE MONTH AFTER THE INITIAL SURGERY DUE TO A PERIPROSTHETIC FRACTURE. THE CUP, HEAD, AND LINER WERE REVISED. THE STEM REMAINS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172832 AVENIR FEMORAL STEM CEMENTLESS COLLARED STANDARD OFFSET 12/14 TAPER SIZE 4 PROTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 3160371 00889024509030

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention| H