BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 21302706 · Received February 4, 2025

    Report

    Report Number
    1226188-2025-00006
    Event Type
    Malfunction
    Date Received
    February 4, 2025
    Date of Event
    January 8, 2025
    Report Date
    March 21, 2025
    Manufacturer
    OMNILIFE SCIENCE
    Product Code
    JWH
    PMA / PMN Number
    K060192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PER (B)(4)- FINAL REPORT. ADDITIONAL INFORMATION INCLUDING IF THIS WAS DETECTED DURING SURGERY, IF THERE IT WAS AN ISSUE WITH THE PATELLA IMPLANT OR THE FIT, IF THE EXPLANTED PATELLA WAS AVAILABLE FOR RETURN, CONFIRMATION OF THE DEVICE PART NUMBER AND PICTURES OF THE DEVICES, HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT. THE REPORTER CONFIRNED THAT THE EVENT OCCURRED DURING SURGERY AND THAT THE DEVICE WAS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED. A LOT CODE HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WERE IDENTIFIED AND REVIEWED. ALL FINISHED PARTS ASSOCIATED WITH THESE RECORDS WERE MANUFACTURED AND PACKED TO THE CORRECT SPECIFICATIONS AT THE TIME OF MANUFACTURE. TO PROGRESS WITH THIS INVESTIGATION, A PATELLA FROM THE SAME BATCH WAS TAKEN FROM THE STOCK AND CHECKED . FOLLOWING MEASUREMENTS AND A FUNCTIONAL TEST, IT WAS CONFIRMED THAT THE IMPLANT DOES NOT APPEAR TO HAVE ANY DIMENSIONAL, VISUAL OR MECHANICAL DEFECTS. THIS IS THE FIRST TIME THAT AN INCIDENT REGARDING AN IMPLANT THAT WAS NOT FITTING CORRECTLY HAS BEEN REPORTED FOR THE PRODUCT FAMILY KC-403XX AND THUS THE EVENT IS CONSIDERED TO BE AN ISOLATED CASE. BASED ON THE ABOVE INVESTIGATION, NO FURTHER INVESTIGATION CAN BE CONDUCTED AND THE ROOT CAUSE OF THIS EVENT IS NOT DETERMINED. THIS CASE IS NOW CONSIDERED CLOSED. 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

    PER -9120 INITIAL REPORT. ADDITIONAL INFORMATION INCLUDING IF THIS WAS DETECTED DURING SURGERY, IF THERE IT WAS AN ISSUE WITH THE PATELLA IMPLANT OR THE FIT, IF THE EXPLANTED PATELLA WAS AVAILABLE FOR RETURN AND CONFIRMATION OF THE DEVICE PART NUMBER, HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. A LOT CODE HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING AND STERILISATION RECORDS WERE IDENTIFIED AND WILL BE REVIEWED. 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 PATELLA WAS IMPLANTED AND HAD TO BE REMOVED AS THE EDGE OF THE 10 MM THICK PATELLA WAS CATCHING ON THE FEMUR IMPLANT AND CLICKING. A 8MM THINK PATELLA WAS IMPLANTED.

    Description of Event or Problem · 0

    APEX PATELLA WAS IMPLANTED AND HAD TO BE REMOVED AS THE EDGE OF THE 10 MM THICK PATELLA WAS CATCHING ON THE FEMUR IMPLANT AND CLICKING. A 8MM THINK PATELLA WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363498 APEX KNEE SYSTEM PATELLA JWH OMNILIFE SCIENCE KC-40320 558295

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown