BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETABULAR CUP HAP SIZE 44/50

    MDR report key: 8547502 · Received April 24, 2019

    Report

    Report Number
    3005975929-2019-00167
    Event Type
    Injury
    Date Received
    April 24, 2019
    Date of Event
    April 9, 2019
    Report Date
    September 25, 2020
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    UDI-DI
    03596010502773
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A BHR HEAD (DETAILS VISUALLY CONFIRMED 121142, 23804 SN (B)(6), AND BHR CUP (DETAILS VISUALLY CONFIRMED 120150, 24403, SN (B)(6)) WHICH WAS USED IN TREATMENT WERE RECEIVED FOR INVESTIGATION FOLLOWING LEFT HIP REVISION SURGERY. 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. THE PRODUCTION RECORDS WERE REVIEWED FOR THE RETURNED 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. VISUAL INSPECTION WAS CARRIED OUT ON THE RETURNED DEVICES. FINE SCRATCHES WERE OBSERVED ON THE BEARING SURFACE OF THE HEAD. FINE SCRATCHES WERE NOTED ON THE BEARING SURFACE OF THE CUP. THE AVAILABLE MEDICAL DOCUMENTS WERE REVIEWED. WEAR ANALYSIS WAS PERFORMED TO REVIEW LINEAR WEAR ON THE BEARING SURFACE OF THE HEAD AND CUP. THE WEAR IMAGES IDENTIFIED A WEAR PATCH ON THE BEARING SURFACE FOR THE HEAD, AND A WEAR PATCH ON THE BEARING SURFACE OF THE CUP. MAXIMUM LINEAR WEAR FOR THE HEAD WAS 6.2¿M. ON THE CUP, MAXIMUM LINEAR WEAR WAS 6.1¿M, FOR A COMBINED HEAD & CUP MAXIMUM WEAR OF 12.3¿M. BASED ON HISTORIC WEAR DATA, AFTER 15.7 YEARS IN VIVO, THE MEASURED COMBINED LINEAR WEAR IS IN LINE WITH THE EXPECTED WEAR FOR A NON-EDGE LOADED SMITH AND NEPHEW LARGE DIAMETER METAL-ON-METAL DEVICE. THE POSITION OF WEAR ON THE ACETABULAR CUP SHOWS THAT THE FEMORAL HEAD WAS ARTICULATING WITHIN THE BEARING SURFACE OF THE CUP. THE AVAILABLE MEDICAL DOCUMENTS WERE REVIEWED. THE PATIENT¿S PREEXISTING AVN CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR TO THE LUCENCY AND SUBSEQUENT REVISION. THE ROOT CAUSE FOR THE HETEROTOPIC OSSIFICATION CANNOT BE CONCLUDED BUT SOME PATIENTS CAN BE GENETICALLY PREDISPOSED IT IS A KNOWN COMPLICATION OF JOINT SURGERIES AND IS RELATED TO THE PROCEDURE AND NOT THE DEVICE. THE ROOT CAUSE OF THE REPORTED PAIN, MINIMAL LUCENCY AND HETEROTOPIC OSSIFICATION CANNOT BE CONFIRMED AND IT CANNOT BE CONCLUDED THAT THE REPORTED CLINICAL REACTIONS WERE ASSOCIATED WITH A MAL-PERFORMANCE OF THE IMPLANT. THE PATIENT IMPACT BEYOND THE PAIN, REVISION, AND EXPECTED TRANSIENT POST-OP CONVALESCENCE PERIOD CANNOT BE DETERMINED. BASED ON THE AVAILABLE INFORMATION A ROOT CAUSE CANNOT BE FOUND. IF THE ADDITIONAL INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS CASE WILL BE REOPENED. NO PREVENTATIVE OR CORRECTIVE ACTION HAS BEEN INITIATED AS A RESULT OF THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED SINCE FEMORAL HEAD COLLAPSE DUE TO THE PROGRESSION OF THE PATIENT AVN DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340672 ACETABULAR CUP HAP SIZE 44/50 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD 74122150 24403 03596010502773

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R 74121142 RESURF FEM HEAD 42MM 23804