BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOS 16X150MM SPL TPR DIST

    MDR report key: 13206109 · Received January 10, 2022

    Report

    Report Number
    0001825034-2022-00072
    Event Type
    Malfunction
    Date Received
    January 10, 2022
    Date of Event
    December 16, 2021
    Report Date
    February 18, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304474239
    PMA / PMN Number
    K090757
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A COMBINATION PRODUCT (B)(4). CONCOMITANT MEDICAL PRODUCTS: 31-301300 ZB6654830 ARCOS CON SZ A STD 50MM TRL; 110010244 6555081 G7 OSSEOTI 3 HOLE SHELL 52MM E; 650-0661 3062863 DELTA CERAMIC FEM HD 36/0MM; 010001001 6995203 G7 SCREW 6.5MM X 40MM; 30103605 65256549 G7 VIT E NEUTRAL LNR 36MM E. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-00073.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE RETURNED CONE BODY TRIAL IDENTIFIED SCRATCHING AND SCUFFING ON THE OUTER SURFACES OF THE BODY. THE STEM OPENING IS FREE OF DAMAGE OR DEFORMITY. THE INNER TAPER IS FREE OF ANY VISUAL DAMAGE. SCRATCHING AND DEBRIS ARE PRESENT INSIDE THE STEM TAPER. THE LOCKING SCREW RATTLES AND ROTATES FREELY INSIDE THE CONE BODY. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE ARCOS 50MM PROXIMAL BODY CONE TRIAL WOULD NOT ENGAGE WITH THE STEM. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588955 ARCOS 16X150MM SPL TPR DIST PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 156010 00880304474239

    Patients

    Seq Age Sex Outcome Treatment
    1 Female