BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETLR CUP HAP 50MM W/ IMPTR

    MDR report key: 8080957 · Received November 16, 2018

    Report

    Report Number
    3005975929-2018-00463
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    June 13, 2017
    Report Date
    April 15, 2020
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SMITH & NEPHEW IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR, PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. - ATTACHMENT: [220640 SUMMARY.PDF]

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A REVISION SURGERY OF THE RIGHT HIP WAS PERFORMED DUE TO PAIN, BONE LOSS, LARGE PSEUDOTUMOR, OSTEOLYSIS, CORROSION AND METALLOSIS. DURING THE REVISION, THE ACETABULAR CUP, HEMI HEAD AND MODULAR SLEEVE WERE REMOVED. AS OF TODAY, THE IMPLANTED DEVICES, ALL OF WHICH WERE USED IN TREATMENT, AND ADDITIONAL INFORMATION HAVE BEEN REQUESTED FOR THIS COMPLAINT BUT HAVE NOT BECOME AVAILABLE. NO PART/LOT NUMBERS WERE PROVIDED; HENCE DOCUMENTATION REVIEW AND COULD NOT BE COMPLETED. IF MORE INFORMATION IS RECEIVED, THIS INVESTIGATION WILL BE REOPENED. WITHOUT DEFINITIVE PART/LOT NUMBERS A COMPLETE COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED FOR THE DEVICES INVOLVED. A REVIEW OF THE COMPLAINT HISTORY REVIEW WAS PERFORMED USING THE PART NUMBER FOR EACH PART IN SEARCH OF COMPLAINTS INVOLVING METALLOSIS THROUGHOUT THE LIFETIME OF THE PRODUCT. SIMILAR COMPLAINTS HAVE BEEN IDENTIFIED AND THIS FAILURE WILL CONTINUE TO BE MONITORED. WITHOUT THE DETAILS OF THE DEVICES INVOLVED IN THIS COMPLAINT, THE SPECIFIC PRODUCT LABELLING AND IFUS FOR THE DEVICES ALSO CANNOT BE REVIEWED. IF THIS INFORMATION BECOMES AVAILABLE AT A LATER TIME, THE TASK WILL BE REOPENED AND COMPLETED. A RISK MANAGEMENT REVIEW WAS PERFORMED. NO ADDITIONAL RISKS WERE IDENTIFIED AS RESULT OF THE REPORTED EVENT. THE AVAILABLE MEDICAL DOCUMENTS WERE REVIEWED. IT CANNOT BE DETERMINED TO WHAT EXTENT THE PATIENTS FALL HAD ON HER PAIN AND CLINICAL STATUS AS WELL AS THE ANTEVERTED POSITION OF THE ACETABULAR COMPONENT. ALTHOUGH IT WAS REPORTED THE PATIENT HAD ELEVATED COBALT LEVELS, NEITHER THE LEVELS NOR THE LAB REPORTS WERE PROVIDED FOR REVIEW. THE REPORTED ELEVATED COBALT LEVELS, AVULSION FRACTURE OF THE GREATER TROCHANTER AND FLUID COMPONENTS SEEN ON MRI AS WELL AS INTRAOPERATIVE FINDINGS OF EXTENSIVE OSTEOLYSIS AND CORROSION AT THE FEMUR, AND THE SOLID ADVERSE LOCAL TISSUE REACTION MAY BE CONSISTENT WITH FINDINGS OF METAL DEBRIS AND PSUEDOTUMOR, HOWEVER CHANGES IN POSITION OF THE ACETABULAR COMPONENT COULD ALSO ACCELERATE WEAR AND LEAD TO METAL DEBRIS. WITHOUT THE SUPPORTING PATHOLOGY RESULTS, IMAGING, AND/OR EXPLANTED COMPONENTS, THE ROOT CAUSE OF THE ANTEVERTED POSITION OF THE ACETABULAR COMPONENT, METAL DEBRIS AND PSUEDOTUMOR 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. 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 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 A REVISION SURGERY OF THE RIGHT HIP WAS PERFORMED DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921161 ACETLR CUP HAP 50MM W/ IMPTR PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 74122542 HEMI HEAD 42MM| 74222200 MODULAR SLEEVE {} PLUS 0MM 12/14| UNKNOWN BHR DEVICE/UNKNOWN LOT