BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX KNEE

    MDR report key: 16487086 · Received March 6, 2023

    Report

    Report Number
    1226188-2023-00091
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Date of Event
    February 17, 2023
    Report Date
    March 6, 2023
    Manufacturer
    OMNILIFE SCIENCE INC.
    Product Code
    JWH
    PMA / PMN Number
    K060192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CASE-(B)(4), COMBINED REPORT.  THE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT MANUFACTURING RECORDS WERE IDENTIFIED AND REVIEWED. ALL PARTS WERE CLEANED, PACKAGED AND STERILIZED ACCORDING TO SPECIFICATIONS. THE COMPLAINT REPORTER MENTIONED THAT THE STERILITY WAS COMPROMISED WHEN IMPLANTING AN APEX TIBIAL BASEPLATE RETAINING BOLT DUE TO FALLING ON THE GROUND.  THE IFU OF APEX PRODUCT MENTION THAT : "WHEN REMOVING THE IMPLANT FROM IT'S PACKAGING, THE STERILE TECHNIQUE MUST BE OBSERVED. PROTECT PROSTHESIS FROM CONTACT WITH OBJECTS THAT MAY DAMAGE THE SURFACE FINISH." IN THIS CASE THE SURGEON SOAKED THE IMPLANT IN BETADINE AND IMPLANTED IT, AS NO OTHER SIMILAR PRODUCT WAS AVAILABLE. CONSEQUENTLY THE CORIN PRODUCT WAS NOT FAULTY PRIOR TO THE FALL ON THE GROUND IN OR. ANY ADDITIONAL INFORMATION INDICATING A FUTURE IMPACT ON THE PATIENT'S HEALTH STATUS WILL BE REPORTED IN SUPPLEMENTAL REPORT, IF APPLICABLE.  THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE EVENT.  EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE  MARKET IN THE USA, HOWEVER, THIS  EVENT OCCURRED OUTSIDE OF THE USA. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT  THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED  OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    THE APEX TIBIAL BASEPLATE RETAINING BOLT WAS DESTERILISED DUE TO FALLING ON THE GROUND. THE SURGEON SOAKED THE IMPLANT IN BETADINE AND IMPLANTED THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512546 APEX KNEE RETAINING BOLT, CONGRUENT OR ULTRA INSERT, PRIMARY TIBIA BASEPLATE JWH OMNILIFE SCIENCE INC. KC-53000 519502

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other