BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS MODULAR REVISION HIP SYSTEM 13X150MM SPL TPR DIST

    MDR report key: 19033489 · Received April 3, 2024

    Report

    Report Number
    0001825034-2024-00923
    Event Type
    Injury
    Date Received
    April 3, 2024
    Date of Event
    March 17, 2024
    Report Date
    July 11, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304480414
    PMA / PMN Number
    K090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3; H2; H3; H6. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04)- STEM. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE EXPLANTED BEARING, WITH BIO DEBRIS ON THE OUTER SPHERICAL SURFACE, AS WELL AS INSIDE THE BEARING. NO FURTHER EVALUATION CAN BE MADE. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. ASSESSED 2 IMAGES FOR MMI SUBMISSION AND IT WAS DETERMINED NOT TO SUBMIT IMAGES AT THIS TIME. THE 2 SLICES PROVIDE ONLY PARTIAL BONE AND IMPLANT VISIBILITY WHICH WOULD LIMIT THE RADIOLOGIST'S EVALUATION OF THE REPORTED EVENTS, AS WELL AS THERE IS ARTIFACT PRESENT AND INCOMPLETE VISIBILITY OF CERCLAGE WIRES AROUND THE FEMUR. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT WAS REPORTED THE PATIENT FELL, HOWEVER THE REASON FOR THE FALL IS UNKNOWN. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 010000700, LOT# 7120505, G7 BONEMASTER LTD ACET SHL 46B. CAT# 163652, LOT# 267420, 22.2MM DIA COCR MOD HD -5 NK. CAT# 11-301300, LOT# 600400, ARCOS CON SZ A STD 50MM. G2: FOREIGN ¿ AUSTRALIA. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2024 - 00922 AND 0001825034 - 2024 - 00924. 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY TWO YEARS POST-IMPLANTATION DUE TO A FEMUR FRACTURE AND THE BEARING WAS DISASSOCIATED FROM THE LINER. ONLY THE BEARING WAS REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822393 ARCOS MODULAR REVISION HIP SYSTEM 13X150MM SPL TPR DIST PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 019220 00880304480414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H