BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETABULAR CUP HAP SIZE 48/54

    MDR report key: 8622140 · Received May 17, 2019

    Report

    Report Number
    3005975929-2019-00216
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    January 1, 1901
    Report Date
    April 21, 2020
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT HAD LEFT HIP PAIN, FLUID BUILDUP, ELEVATED LEVELS OF COBALT AND CHROMIUM, LOSS OF MOBILITY, AND METALLOSIS. NO REVISION SURGERY HAS BEEN CONFIRMED YET. THE IMPLANTED DEVICES WERE ALL USED IN TREATMENT. AS OF TODAY, ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR THIS COMPLAINT BUT HAVE NOT BECOME AVAILABLE. A REVIEW OF THE COMPLAINT HISTORY FOR THE BHR CUP AND BHR HEAD WAS PERFORMED USING BATCH NUMBERS IN SEARCH OF SIMILAR RECURRING REPORTS FOR THE PRODUCTS DURING THEIR LIFETIMES. NO OTHER SIMILAR COMPLAINTS WERE IDENTIFIED. IN THE ABSENCE OF THE ACTUAL DEVICES, THE PRODUCTION RECORDS WERE REVIEWED FOR THE DEVICES REPORTEDLY INVOLVED IN THIS INCIDENT. ALL THE RELEASED DEVICES INVOLVED MET MANUFACTURING SPECIFICATIONS AT THE TIME OF PRODUCTION. REVIEW OF THE PRODUCT IFU FOUND ADEQUATE WARNINGS AND PRECAUTIONS IN RELATION TO THE ALLEGED FAILURE MODES. A RISK MANAGEMENT REVIEW WAS PERFORMED. NO ADDITIONAL RISKS WERE IDENTIFIED AS RESULT OF THE REPORTED EVENT AND NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THE AVAILABLE MEDICAL DOCUMENTS WERE REVIEWED. IT WAS REPORTED THAT THE PATIENT HAD LEFT HIP PAIN, FLUID BUILDUP, ELEVATED LEVELS OF COBALT AND CHROMIUM, LOSS OF MOBILITY, AND METALLOSIS. THE IMPLANTATION OPERATIVE REPORT INDICATES THE PATIENT HAD A LEFT BHR DONE 03/01/2011 FOR OSTEOARTHRITIS. THE OPERATIVE REPORT DID NOT AID IN THE MEDICAL ASSESSMENT INVESTIGATION. WITHOUT SUPPORTING MEDICAL DOCUMENTATION, A THOROUGH MEDICAL ASSESSMENT OF THE REPORTED EVENT CANNOT BE PERFORMED. IN THE EVENT ADDITIONAL MEDICAL/CLINICAL RECORDS ARE RECEIVED, THE CLINICAL TASK WILL BE REOPENED AND A THOROUGH ASSESSMENT WILL BE RENDERED AT THAT TIME. WITHOUT RETURN OF THE ACTUAL DEVICES OR FURTHER INFORMATION WE CANNOT FURTHER INVESTIGATE OR CONFIRM THE DETAILS SUPPLIED IN THIS COMPLAINT, AND OUR INVESTIGATION REMAINS INCONCLUSIVE. IF THE PRODUCTS OR ADDITIONAL INFORMATION BECOME AVAILABLE IN THE FUTURE, THIS CASE WILL BE RE-OPENED. NO PREVENTATIVE OR CORRECTIVE ACTION HAS BEEN INITIATED AS A RESULT OF THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD LEFT HIP PAIN, FLUID BUILDUP, ELEVATED LEVELS OF COBALT AND CHROMIUM, LOSS OF MOBILITY, AND METALLOSIS. NO REVISION SURGERY HAS BEEN CONFIRMED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415468 ACETABULAR CUP HAP SIZE 48/54 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD 10HW29485

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 74123148 FEMORAL HEAD 48MM 10HW29554| FEMORAL HEAD, PART AND LOT # UNKNOWN