BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN SMITH+NEPHEW DEV

    MDR report key: 11904904 · Received May 28, 2021

    Report

    Report Number
    1020279-2021-04806
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    May 1, 2018
    Report Date
    August 30, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LDQ
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, THE REQUESTED SURGICAL RECORDS AND X-RAYS HAVE NOT BEEN PROVIDED, THEREFORE, A THOROUGH MEDICAL ASSESSMENT CANNOT BE RENDERED. THE PATIENT IMPACT AND CLINICAL ROOT CAUSE OF THE INFECTION AND REVISION CANNOT BE DETERMINED. SHOULD ADDITIONAL CLINICALLY RELEVANT DOCUMENTATION BECOME AVAILABLE, THE CLINICAL/MEDICAL TASK MAY BE RE-OPENED. NO FURTHER ASSESSMENT IS WARRANTED AT THIS 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 NOT LIMITED TO FIT/SIZING ISSUE, LIFETIME OF DEVICE, PATIENT CONDITION/REACTION, TRAUMATIC INJURY, JOINT TIGHTNESS, MATERIAL IN USE OR LOSS OF STERILITY. 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. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AFTER A TKA, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 DUE TO ALL OF THE UNKN LEGION KNEE IMPLANT AND UNKN JOURNEY KNEE IMPLANT REPLACED BECAUSE PARTS WERE PAINFUL AND UNSTABLE. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797242 UNKN SMITH+NEPHEW DEV DEVICE, GENERAL MEDICAL LDQ SMITH & NEPHEW, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1