BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN R3 METAL LINER IMPL

    MDR report key: 13759825 · Received March 14, 2022

    Report

    Report Number
    3005975929-2022-00057
    Event Type
    Injury
    Date Received
    March 14, 2022
    Date of Event
    October 17, 2020
    Report Date
    June 9, 2022
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). THOMPSON, Z., KHOSHBIN, A., WARD, S., WADDELL, J. P., & ATREY, A. (2020). THE EARLY-TO MEDIUM-TERM RESULTS OF A HEMISPHERICAL, POROUS COATED ACETABULAR SHELL WITH MULTIPLE DIFFERENT BEARING COMBINATIONS ARE EXCELLENT WITH THE EXCEPTION OF METAL-ON-METAL. INTERNATIONAL ORTHOPAEDICS, 44(12), 2537-2543. DOI: DOI.ORG/10.1007/S00264-020-04817-1.

    Additional Manufacturer Narrative · 0

    H3, H6: IT WAS REPORTED THAT ON LITERATURE REVIEW 2 PATIENTS HAD A TWO-STAGE REVISION SURGERY DUE TO A DEEP INFECTION AFTER A THA WHILE USING R3 ACETABULAR SHELL AND HIGH OFFSET POROUS-COATED SYNERGY STEM. THE EVENTS WERE TREATED BY A REVISION SURGERY. PATIENTS¿ OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. WITHOUT DEFINITIVE LOT NUMBERS, A COMPLETE COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED FOR THE DEVICES INVOLVED. AS NO DEVICE BATCH NUMBERS WERE PROVIDED FOR INVESTIGATION, A MANUFACTURING RECORD REVIEW, STERILIZATION REVIEW, DEVICE LABELLING AND IFU REVIEW COULD NOT BE PERFORMED. A RISK MANAGEMENT REVIEW COULD NOT BE PERFORMED AS THE DEVICES INVOLVED HAVE BEEN PHASED OUT FROM THE MARKET AND AS A RESULT THERE IS NO LIVE RISK MANAGEMENT FILE TO REVIEW. WITHOUT DEFINITIVE LOT NUMBERS A FULL REVIEW OF PRIOR ESCALATION ACTIONS CANNOT BE PERFORMED FOR THE DEVICES INVOLVED. HOWEVER, USING THE AVAILABLE INFORMATION, A SEARCH WAS COMPLETED. FOLLOWING THE REVIEW, PRIOR APPLICABLE ESCALATION ACTIONS WERE IDENTIFIED AND CONFIRMED TO REDUCE ASSOCIATED RISKS AS FAR AS POSSIBLE; NO FURTHER ESCALATION ACTIONS REQUIRED. WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. THE IMAGES PROVIDED IN THE ARTICLE HAVE BEEN INTERPRETED WITHIN THE TEXT; THEREFORE, NO FURTHER ANALYSIS OF THE IMAGES ARE REQUIRED. THE ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE COULD NOT BE CONFIRMED NOR CONCLUDED. SHOULD CLINICAL DOCUMENTATION BECOME AVAILABLE IN THE FUTURE, A THOROUGH MEDICAL ASSESSMENT MAY BE RENDERED AT THAT TIME WITHOUT ADDITIONAL INFORMATION WE CANNOT FURTHER INVESTIGATE OR CONFIRM THE REPORTED COMPLAINT. THE INVESTIGATION REMAINS INCONCLUSIVE, AND A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. ADDITIONALLY, SPECIFIC FACTORS KNOWN TO CONTRIBUTE TO THE ALLEGED FAULT CANNOT BE PROVIDED DUE TO THE INSUFFICIENT INFORMATION. IF THE PRODUCTS OR ADDITIONAL INFORMATION BECOME AVAILABLE IN THE FUTURE, THIS CASE WILL BE REOPENED. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE OR PREVENTATIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "THE EARLY TO MEDIUM-TERM RESULTS OF A HEMISPHERICAL, POROUS COATED ACETABULAR SHELL WITH MULTIPLE DIFFERENT BEARING COMBINATIONS ARE EXCELLENT WITH THE EXCEPTION OF METAL-ON-METAL", TWO (2) PATIENTS HAD A TWO-STAGE REVISION SURGERY DUE TO A DEEP INFECTION AFTER A THA WHILE USING R3 ACETABULAR SHELL AND HIGH OFFSET POROUS-COATED SYNERGY STEM. THE EVENTS WERE TREATED BY A REVISION SURGERY. PATIENTS¿ OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338284 UNKN R3 METAL LINER IMPL PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVE