BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAIPH KNEE

    MDR report key: 9595657 · Received January 16, 2020

    Report

    Report Number
    3008985661-2020-00002
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Date of Event
    December 17, 2019
    Report Date
    January 16, 2020
    Manufacturer
    MATORTHO LIMITED
    Product Code
    JWH
    UDI-DI
    05055455506657
    PMA / PMN Number
    K140222
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON THE (B)(6) 2019 PART NUMBER 193-744 WAS EXPLANTED AND PART NUMBER 193-746 SAIPH® FIXED TIBIAL BEARING RED RIGHT SIZE C 18MM, LOT 203054, EXPIRY DATE 2023-01-01 WAS SUCCESSFULLY IMPLANTED. THE DEVICE HISTORY RECORD RELATING TO THE MANUFACTURE OF PART NUMBER 193-744, LOT 202468 WAS REVIEWED WHICH CONFIRMED THAT NO NONCONFORMING PRODUCT WAS RELEASED. THE PATIENT PRESENTED WITH "HYPERFLEXED KNEE" AND AN 18MM BEARING WAS IMPLANTED WHICH COULD INFER (AFTER 6 YEARS 7 MONTHS IN SITU) THAT THE CAUSE OF THIS NOTIFICATION WAS THAT THE JOINT HAD BECOME LOOSE / UNSTABLE.

    Description of Event or Problem · 1

    "REVISION RIGHT KNEE (SAIPH) WAS DONE BY MR (B)(6) AT THE (B)(6) HOSPITAL ON TUESDAY, (B)(6) 2019." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57593 SAIPH KNEE SAIPH® FIXED TIBIAL BEARING RED RIGHT SIZE C 14MM JWH MATORTHO LIMITED 202468 05055455506657

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other