BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN REFLECTION LINER POLY

    MDR report key: 12780211 · Received November 9, 2021

    Report

    Report Number
    1020279-2021-07930
    Event Type
    Injury
    Date Received
    November 9, 2021
    Date of Event
    October 19, 2021
    Report Date
    January 21, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE NUMBER: CASE-(B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: THE ASSOCIATED DEVICE WAS NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE CORROBORATED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, NO RELEVANT SUPPORTING CLINICAL INFORMATION HAS BEEN PROVIDED TO ASSIST WITH A CLINICAL INVESTIGATION. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AND THE PATIENT IMPACT BEYOND THE REPORTED EVENTS COULD NOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED. THEREFORE, BASED ON INSUFFICIENT INFORMATION, A THOROUGH CLINICAL ASSESSMENT CANNOT BE PERFORMED AT THIS TIME. SHOULD ANY ADDITIONAL CLINICAL INFORMATION BE PROVIDED THIS COMPLAINT WILL BE RE-EVALUATED. 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 NOT LIMITED TO LIFETIME OF DEVICE, WEAR OR PATIENT CONDITION. 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 DEVICE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED 25 YEARS AGO, THE PATIENT EXPERIENCED INSTABILITY. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021. 28 LINER AND COCR 12/14 FEM HEAD 28 +0 WERE REPLACED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676459 UNKN REFLECTION LINER POLY PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI SMITH & NEPHEW, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R COCR 12/14 FEM HEAD 28 +0