BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN R3 SHELL

    MDR report key: 13764654 · Received March 14, 2022

    Report

    Report Number
    1020279-2022-01152
    Event Type
    Injury
    Date Received
    March 14, 2022
    Date of Event
    January 22, 2021
    Report Date
    April 7, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: CASE-(B)(4). "ACETABULAR SCREWS DO NOT IMPROVE EARLY REVISION RATES IN PRIMARY TOTAL HIP ARTHROPLASTY. AN INSTRUMENTED REGISTRY ANALYSIS" DOI: DOI.ORG/10.1007/S00264-021-0.

    Additional Manufacturer Narrative · 0

    H3, H6: 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 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. FACTORS AND/OR SOME POTENTIAL PROBABLE CAUSES THAT COULD CONTRIBUTE TO THE REPORTED EVENT HAVE BEEN IDENTIFIED AS OVERUSE OR EXCESSIVE PRESSURE ON THE JOINT, INJURY, INFECTION AND/OR PATIENT CONDITION. 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 "ACETABULAR SCREWS DO NOT IMPROVE EARLY REVISION RATES IN PRIMARY TOTAL HIP ARTHROPLASTY. AN INSTRUMENTED REGISTRY ANALYSIS", DATA WAS COLLECTED FROM THE AUSTRALIAN ORTHOPAEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR) FROM 1-SEP-1999 TO 31-DEC-2018. THREE HUNDRED THIRTY THOUSAND ONE HUNDRED NINETY-TWO THAS FROM DIFFERENT MANUFACTURERS WERE EVALUATED ACCORDING TO IMPLANT SURVIVAL RATE. IT WAS REPORTED THAT FROM 13.520 THAS PERFORMED USING THE R3 SYSTEM WITHOUT SCREWS, 329 SUFFERED FROM AN UNSPECIFIED CONDITION THAT REQUIRED A REVISION SURGERY.THE OUTCOME OF THE PATIENTS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663730 UNKN R3 SHELL PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL JDG SMITH & NEPHEW, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R