BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSYS HIP SYSTEM PROXIMAL CENTRALIZER

    MDR report key: 4092716 · Received August 20, 2014

    Report

    Report Number
    1822565-2014-00999
    Event Type
    Malfunction
    Date Received
    August 20, 2014
    Date of Event
    July 7, 2014
    Report Date
    May 8, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK954744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: THE DEVICE HAS BEEN SHIPPED AN UNK NUMBER OF TIMES DURING ITS POTENTIAL FIELD AGE. THE SHIPPING CONDITIONS OF THIS DEVICE IS UNK. A COMPLAINT HISTORY SEARCH OF THE MANUFACTURING LOT RETURNED NO ADDITIONAL COMPLAINTS. THERE IS NO PATIENT RISK ASSOCIATED WITH UNAVAILABILITY OF THE PROXIMAL CENTRALIZER AS IT IS AN OPTIONAL PREPARATION OF THE STEM. WITH THE INFO PROVIDED, A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED. EVALUATION CODES: THE RETURNED CENTRALIZER IS BROKEN IN HALF. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE WORK ORDER HISTORY WAS REVIEWED AND ALL MANUFACTURING JOB STEPS WERE PERFORMED AND COMPLETED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF PREVIOUS MEDWATCH REPORTS FILE. COMPLAINT SAMPLE WAS EVALUATED AT TIME OF RECEIPT, AND THE REPORTED EVENT WAS CONFIRMED. THIS COMPLAINT FILE WAS RE-OPENED FOR FURTHER INVESTIGATION AS A COMPLAINT-OUT-OF-BOX THROUGH CORRECTIVE AND PREVENTIVE ACTIONS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND NO DEVIATIONS OR ANOMALIES THAT WOULD APPEAR TO CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. A CURRENT COMPLAINT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINT FOR THIS REPORTED PART/LOT COMBINATION. THE MOST LIKELY ROOT CAUSE OF THE PRODUCT DAMAGE APPEARS TO BE DUE TO TRANSIT; HOWEVER, CORRECTIVE AND PREVENTIVE ACTIONS ARE ONGOING AT THIS TIME. 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 · 1

    IT IS REPORTED THAT THE SCRUB TECH RECEIVED THE IMPLANT BROKEN, STILL IN THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500666 VERSYS HIP SYSTEM PROXIMAL CENTRALIZER JDI JDI ZIMMER, INC. 624551177

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR