BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETLR CUP HAP 50MM W/ IMPTR

    MDR report key: 8076988 · Received November 16, 2018

    Report

    Report Number
    3005975929-2018-00460
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    May 17, 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: [220465 SUMMARY.PDF]

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED. DURING THE REVISION, THE ACETABULAR CUP, HEMI HEAD, SYNERGY STEM & MODULAR SLEEVE WERE REMOVED. AS OF TODAY, THE IMPLANTED DEVICES, ALL OF WHICH WERE USED IN TREATMENT, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR THIS COMPLAINT BUT HAS NOT BECOME AVAILABLE. A REVIEW OF THE COMPLAINT HISTORY FOR THE CUP/ HEAD/ SLEEVE/ STEM WAS PERFORMED USING BATCH NUMBERS IN SEARCH OF SIMILAR RECURRING REPORTS FOR THE PRODUCTS DURING THEIR LIFETIMES. NO OTHER SIMILAR COMPLAINTS WERE IDENTIFIED FOR THE CUP/ HEAD/ STEM. SIMILAR COMPLAINTS HAVE BEEN IDENTIFIED FOR THE SLEEVE AND THIS FAILURE WILL CONTINUE TO BE MONITORED. IN THE ABSENCE OF THE ACTUAL DEVICES, THE PRODUCTION RECORDS WERE REVIEWED FOR THE DEVICES REPORTEDLY INVOLVED IN THIS INCIDENT. REVIEW OF MANUFACTURING RECORDS DID NOT REVEAL ANY WAIVERS, CONCESSIONS, MANUFACTURING OR MATERIAL ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. 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. THE MEDICAL DOCUMENTS WERE REVIEWED. THE REPORTED PAIN, ELEVATED METAL IONS AND FEMORAL OSTEOLYSIS AS DEMONSTRATED ON MRI ALONG WITH INTRAOPERATIVE FINDINGS OF A LOCAL TISSUE REACTION, BLACK CORROSION OF THE FEMORAL HEAD, AND PSEUDOTUMOR ALONG WITH PATHOLOGICAL FINDINGS OF A MIXED MACROPHAGIC/LYMPHOCYTIC IMMUNOLOGICALLY MEDIATED REACTION TO IMPLANT CORROSION MAY BE CONSISTENT WITH FINDINGS ASSOCIATED WITH METAL DEBRIS AND ASEPTIC LYMPHOCYTE-DOMINATED VASCULITISASSOCIATED LESION. HOWEVER, THE ROOT CAUSE OF THE REPORTED PSEUDOTUMOR AND ASEPTIC LYMPHOCYTEDOMINATED VASCULITIS-ASSOCIATED LESION 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 RIGHT HIP REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917290 ACETLR CUP HAP 50MM W/ IMPTR PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD 58931

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R 71306609 SYN POR FEM COMP SZ 9 06GM03977| 74122542 HEMI HEAD 42MM L#9817| 74222200 MODULAR SLEEVE{}PLUS 0MM 12/14 L#9634A| FEMORAL HEAD, PART AND LOT # UNKNOWN| FEMORAL HEAD, PART AND LOT # UNKNOWN