BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL FEMORAL HEAD 36 S/+0

    MDR report key: 16195923 · Received January 18, 2023

    Report

    Report Number
    9613369-2023-00013
    Event Type
    Malfunction
    Date Received
    January 18, 2023
    Date of Event
    December 27, 2022
    Report Date
    February 15, 2023
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    LZO
    UDI-DI
    07611996121896
    PMA / PMN Number
    K132435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6. IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGERY, A TRIAL FEMORAL HEAD 36 S/+0 BROKE IN A CASE AND PIECE WAS REMOVED. THE DEVICE INTENDED FOR USE IN TREATMENT WAS NOT RETURNED FOR INVESTIGATION. A PRODUCT EVALUATION WAS NOT POSSIBLE. NO BATCH NUMBER WAS COMMUNICATED SO THE DOCUMENT HISTORY REVIEW WAS NOT POSSIBLE. AS THERE IS NO BATCH NUMBER AVAILABLE, THE COMPLAINT HISTORY REVIEW WAS PERFORMED ON PRODUCT NUMBER, REVEALING 10 ADDITIONAL COMPLAINTS REPORTED FOR THE SAME PRODUCT NUMBER OVER THE PAST 12 MONTHS WITH SIMILAR FAILURE MODE. PREVIOUS INVESTIGATIONS DEMONSTRATED THAT THE TRIAL FEMORAL HEAD MAY DISCONNECT FROM THE STEM TAPER INTRA-OPERATIVELY AND FLAPS MIGHT BREAK OFF. THESE FAILURE MODES MAY FURTHER BE EXACERBATED BY EXCESSIVE USE OF THE DEVICE OVER TIME. THE PERFORMANCE OF THE DEVICE IS STILL WITHIN THE RISKS LEVEL THAT ARE ANTICIPATED IN THE RISK MANAGEMENT DOCUMENTATION. THE CURRENT DESIGN WILL BE FURTHER MONITORED THROUGH POST-MARKET SURVEILLANCE PROCESSES. NO FURTHER ACTIONS ARE NECESSARY AT THIS TIME POINT. A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION VERIFIES THE FAILURE MODE, OCCURRENCE AND SEVERITY OF THE REPORTED ISSUE. THE PERFORMED INVESTIGATION DO NOT LEAD TO AN ACCURATELY DETERMINED CAUSE. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO INVESTIGATE WHETHER THE REPORTED DEVICE MET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. DUE TO INSUFFICIENT INFORMATION, IT IS NOT POSSIBLE TO SPECULATE ABOUT FACTORS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ACCORDING TO DOCUMENT "PROCESSING (CLEANING, DISINFECTION AND STERILIZATION) OF INSTRUMENTS FROM SMITH & NEPHEW ORTHOPAEDICS AG" (LIT. N°03389-EN 1363 V3 11/19), ALL DEVICES MUST BE INSPECTED AND CONTROLLED FOR PROPER FUNCTIONING AFTER CLEANING/DISINFECTION. THERE IS NO NEED FOR FURTHER ACTIONS BECAUSE OF THE LIMITED INFORMATION PROVIDED. NEVERTHELESS, SMITH + NEPHEW WILL CONTINUE TO MONITOR THIS DEVICE FOR SIMILAR ISSUES. THIS COMPLAINT WILL BE REOPENED SHOULD ADDITIONAL INFORMATION OR THE DEVICE BE RECEIVED.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: CASE-(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A THR SURGERY, A TRIAL FEMORAL HEAD 36 S/+0 BROKE IN A CASE AND PIECE WAS REMOVED. SURGERY WAS RESUMED, WITHOUT ANY DELAY BUT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14634 TRIAL FEMORAL HEAD 36 S/+0 PROSTHESIS, HIP, SEMI-CONSTRAINED,METALCERAMICPOLYMER,CEMENTED ORNONPOROUS LZO SMITH & NEPHEW ORTHOPAEDICS AG 75100856 UNK 07611996121896

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown