BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 16478464 · Received March 3, 2023

    Report

    Report Number
    1226188-2023-00089
    Event Type
    Injury
    Date Received
    March 3, 2023
    Date of Event
    February 15, 2023
    Report Date
    May 17, 2023
    Manufacturer
    OMNILIFE SCIENCE INC.
    Product Code
    JWH
    PMA / PMN Number
    K060192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FINAL REPORT. ADDITIONAL INFORMATION INCLUDING POST PRIMARY AND PRE REVISION X-RAYS, OPERATIVE NOTES (PRIMARY AND REVISION), PATIENT ACTIVITY LEVEL AND MEDICAL HISTORY AND AN UPDATE ON THE PATIENT POST REVISION HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED AND THEREFORE THE SCOPE OF THE INVESTIGATION WAS LIMITED. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING AND STERILIZATION RECORDS WERE IDENTIFIED AND REVIEWED. REVIEW OF THESE RECORDS SHOWED THAT PARTS WERE CLEANED, PACKAGED AND STERILIZED ACCORDING TO SPECIFICATIONS AT THE TIME OF MANUFACTURE. INFECTION IS A KNOWN COMPLICATION WITH ANY INVASIVE SURGERY. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE REPORTED INFECTION COULD NOT BE DETERMINED AND THUS THIS CASE IS NOW CONSIDERED CLOSED. NOTE: THE PART NUMBER KC 53001 PROVIDED IN THE INITIAL REPORT WAS INCORRECT. THE ACCURATE PART NUMBER IS KC 53000. NOTE: 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.

    Additional Manufacturer Narrative · 0

    (B)(4) INITIAL REPORT. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED. THE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. ADDITIONAL INFORMATION WAS REQUESTED, SUCH AS X-RAYS, OPERATIVE NOTES PATIENT ACTIVITY LEVEL, MEDICAL HISTORY AND WEIGHT AND AN UPDATE ON THE PATIENT POST REVISION. CONCLUSIONS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NOTE: 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

    APEX BOLT AND INSERT REVISION DUE TO INFECTION AFTER 5 MONTHS.

    Description of Event or Problem · 0

    APEX BOLT AND INSERT REVISION DUE TO INFECTION AFTER 5 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858208 APEX KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH OMNILIFE SCIENCE INC. KC-53000 503443

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R APEX ULTRA TIBIAL INSERT CS KC-36022 LOT 37678