BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAIPH KNEE

    MDR report key: 8694843 · Received June 13, 2019

    Report

    Report Number
    3008985661-2019-00006
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    June 5, 2019
    Report Date
    October 8, 2019
    Manufacturer
    MATORTHO LIMITED
    Product Code
    JWH
    UDI-DI
    05055455506176
    PMA / PMN Number
    K140222
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOTIFICATION WAS RECEIVED THAT A SAIPH REVISION LEFT KNEE WAS PLANNED FOR (B)(6) 2019. INFORMATION WAS PROVIDED ON (B)(6) 2019 WHICH STATED THAT THE IMPLANTS WERE EXPLANTED AND A REVISION SYSTEM FROM ANOTHER COMPANY WAS IMPLANTED. IT WAS STATED THAT THE REVISION WAS REQUIRED DUE TO TIBIAL ROTATION. THE DEVICE HISTORY RECORD RELATING TO THE MANUFACTURE OF PART NUMBER 193-602 LOT 224553 WAS PERFORMED WHICH CONFIRMED THAT NO NON-CONFORMING PRODUCT WAS RELEASED. DURING THE INVESTIGATION IT WAS IDENTIFIED THAT A POSSIBLE CONTRIBUTING FACTOR WAS A PATIENT SPECIFIC GUIDE WHICH HAD BEEN USED, SUPPLIED BY KICO KNEE INNOVATION COMPANY PTY LTD. AN INVESTIGATION RESPONSE WAS SUPPLIED BY KICO ON (B)(6) 2019 TO MATORTHO WHERE THEY CONCLUDED "BASED ON AVAILABLE OBJECTIVE EVIDENCE OF INSPECTION DOCUMENTS, TRAINING RECORDS OF OPERATORS, GUIDE DESIGN INVESTIGATION AND DISTRIBUTION OF THE PSG. KICO IS UNABLE TO IDENTIFY ANY INSTANCES WHERE AN OVER RESECTION CAN BE ATTRIBUTED TO DESIGN OR INTENDED USE OF THE KICO PSG." THE INVESTIGATION HAS CONCLUDED THAT THE REVISION WAS POSSIBLY DUE TO INTRAOPERATIVE ERRORS I.E. USER ERROR.

    Description of Event or Problem · 0

    A NOTIFICATION WAS RECEIVED STATING THAT A REVISION LEFT KNEE (SAIPH) WAS PLANNED FOR (B)(6) 2019. (B)(4).

    Additional Manufacturer Narrative · 1

    NOTIFICATION WAS RECEIVED THAT A SAIPH REVISION LEFT KNEE WAS PLANNED FOR (B)(6) 2019. INFORMATION WAS PROVIDED ON (B)(6) 2019 WHICH STATED THAT THE IMPLANTS WERE EXPLANTED AND A REVISION SYSTEM FROM ANOTHER COMPANY WAS IMPLANTED. IT WAS STATED THAT THE REVISION WAS REQUIRED DUE TO TIBIAL ROTATION. THE DEVICE HISTORY RECORD RELATING TO THE MANUFACTURE OF PART NUMBER 193-602, LOT 224553 WAS PERFORMED WHICH CONFIRMED THAT NO NONCONFORMING PRODUCT WAS RELEASED.

    Description of Event or Problem · 1

    A NOTIFICATION WAS RECEIVED STATING THAT A REVISION LEFT KNEE (SAIPH) WAS PLANNED FOR (B)(6) 2019. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488650 SAIPH KNEE SAIPH FIXED TIBIAL TRAY CEMENTED SIZE C JWH MATORTHO LIMITED 224553 05055455506176

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other