BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN ORTHOPAEDIC RECONSTRUCTION DEV

    MDR report key: 12878009 · Received November 26, 2021

    Report

    Report Number
    1020279-2021-08421
    Event Type
    Injury
    Date Received
    November 26, 2021
    Date of Event
    November 4, 2021
    Report Date
    January 25, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KDG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICES WERE NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CONTRIBUTION OF THE DEVICES TO THE REPORTED EVENT COULD NOT BE CORROBORATED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT SMITH AND NEPHEW HAS NOT RECEIVED THE DEVICES/ ADEQUATE MATERIALS TO FULLY EVALUATE THE COMPLAINT, BUT IF ADDITIONAL CLINICALLY RELEVANT MATERIALS ARE LATER RECEIVED, THEN THE CASE MAY BE RE-OPENED FOR FURTHER EVALUATION. 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 TRAUMATIC INJURY, JOINT TIGHTNESS, MATERIAL IN USE, PATIENT REACTION 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 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

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER A THA, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO PAIN. THE SURGEON STATED THE DEVICES WERE NOT DEFECTIVE. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776506 UNKN ORTHOPAEDIC RECONSTRUCTION DEV CHISEL (OSTEOTOME) KDG SMITH & NEPHEW, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown