BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REF XLPE 26 20 DEG 46-48 D

    MDR report key: 7336536 · Received March 13, 2018

    Report

    Report Number
    1020279-2018-00313
    Event Type
    Injury
    Date Received
    March 13, 2018
    Date of Event
    February 1, 2018
    Report Date
    April 17, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JPH
    UDI-DI
    03596010455567
    PMA / PMN Number
    K002747
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED REFLECTION ACETABULAR LINER WAS NOT RETURNED FOR EVALUATION. WITHOUT THE EXPLANT OR THE REQUESTED CLINICAL INFORMATION, THE ROOT CAUSE OF THE WEAR CANNOT BE CONCLUDED. THE FUTURE IMPACT TO THE PATIENT BEYOND THE REVISION CANNOT BE DETERMINED. NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED AND NO BATCH INFORMATION AVAILABLE, OUR INVESTIGATION CANNOT PROCEED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE WEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179188 REF XLPE 26 20 DEG 46-48 D TEST, ERYTHROCYTE SEDIMENTATION RATE JPH SMITH & NEPHEW, INC. 03596010455567

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention