BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL BALL HEAD 32 XL/+12 CONE

    MDR report key: 11780342 · Received May 5, 2021

    Report

    Report Number
    9613369-2021-00174
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    April 13, 2021
    Report Date
    August 16, 2021
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    JDH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H6: IT WAS REPORTED THAT DURING AN INSPECTION, IT WAS NOTICED THAT THE TABS AROUND THE CONE OF A TRIAL BALL HEAD 32 XL/+12 CONE WERE WEAKENED, MAKING THE TRIAL NOT FIT WELL. NO CASE INVOLVED. THE COMPLAINT DEVICE, INTENDED FOR USE IN TREATMENT, WAS NOT RETURNED FOR INVESTIGATION. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE COMPLAINT HISTORY REVIEW WAS CONDUCTED. THE PRODUCTION DOCUMENTATION REVIEW COULD NOT BE PERFORMED SINCE THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED. DUE TO INSUFFICIENT INFORMATION IT IS NOT POSSIBLE TO SPECULATE ABOUT FACTORS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT AND THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED CONCLUSIVELY. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE CANNOT BE CONFIRMED. SHOULD THE COMPLAINT DEVICE AND FURTHER INFORMATION BECOME AVAILABLE, THE COMPLAINT INVESTIGATION WILL BE REOPENED. NO FURTHER ACTIONS ARE DEEMED NECESSARY AT THIS POINT. SMITH + NEPHEW WILL CONTINUE TO MONITOR FOR SIMILAR ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INSPECTION, IT WAS NOTICED THAT THE TABS AROUND THE CONE OF A TRIAL BALL HEAD 32 XL/+12 CONE WERE WEAKENED, MAKING THE TRIAL NOT FIT WELL. NO CASE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676133 TRIAL BALL HEAD 32 XL/+12 CONE PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL JDH SMITH & NEPHEW ORTHOPAEDICS AG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1