BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSYS ADVOCATE FEMORAL STEM

    MDR report key: 7064901 · Received November 28, 2017

    Report

    Report Number
    0002648920-2017-00724
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Report Date
    November 7, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    PK950312
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. A VERSYS ADVOCATE FEMORAL STEM AND A VERSYS FEMORAL HEAD PROVISIONAL WERE RETURNED FOR EVALUATION. AS RETURNED, THE STEM IS IN EXCELLENT CONDITION AND SHOWS NO SIGNS OF DAMAGE TO THE TAPER. THE FEMORAL HEAD PROVISIONAL EXHIBITS DAMAGE TO THE OUTER SPHERE AND CONICAL TAPER. DAMAGE IS TOO SEVERE FOR DIMENSIONAL ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES WOULD CONTRIBUTE TO REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00789502602, FEMORAL HEAD PROVISIONAL 12/14 NECK TAPER, 60325007. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001822565-2017-08094.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SURGEON WAS TRYING TO PULL OFF THE HEAD PROVISIONAL FROM THE STEM THE STEM CAME OUT OF THE FEMUR. THE SURGERY WAS FINISHED WITH A BACKUP 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842728 VERSYS ADVOCATE FEMORAL STEM PROSTHESIS, HIP JDI ZIMMER MANUFACTURING B.V. N/A 62955177

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention