BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN R3 SHELL

    MDR report key: 13765446 · Received March 15, 2022

    Report

    Report Number
    1020279-2022-01155
    Event Type
    Injury
    Date Received
    March 15, 2022
    Date of Event
    October 17, 2020
    Report Date
    April 8, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDG
    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

    THE DEVICES WERE NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT 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; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD CLINICAL DOCUMENTATION BECOME AVAILABLE IN THE FUTURE, A THOROUGH MEDICAL ASSESSMENT MAY BE RENDERED AT THAT TIME. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. POSSIBLE CAUSES COULD INCLUDE BUT ARE NOT LIMITED TO CONTAMINATION, PATIENT REACTION, AND POST-OPERATIVE HEALING ISSUE. THE CONTRIBUTION OF THE DEVICES TO THE REPORTED EVENT COULD NOT BE CORROBORATED. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION COULD NOT PROCEED. SHOULD THE DEVICES OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    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
    695183 UNKN R3 SHELL PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL JDG SMITH & NEPHEW, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H