BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAIPH® KNEE

    MDR report key: 9595656 · Received January 16, 2020

    Report

    Report Number
    3008985661-2020-00001
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Date of Event
    December 4, 2019
    Report Date
    January 16, 2020
    Manufacturer
    MATOTHO LTD.
    Product Code
    JWH
    UDI-DI
    05055455506701
    PMA / PMN Number
    K140222
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTIFICATION WAS RECEIVED STATING THAT ON (B)(6) 2019 MR (B)(6) HAD PERFORMED A SECOND REVISION ON A PATIENT WHERE THE POLY HAD BEEN REPLACED. THE PREVIOUS REVISION WAS PERFORMED ON (B)(6) 2019 WHERE A 30MM PATELLA WAS EXPLANTED AND A 26MM PATELLA WAS IMPLANTED ((B)(4), MFR REPORT 3008985661-2019-00003). ON THE (B)(6) 2019 PART NUMBER 193-749 WAS EXPLANTED AND PART NUMBER 193-750 SAIPH® FIXED TIBIAL BEARING BLUE LEFT SIZE C 14MM, LOT 207812, EXPIRY DATE 2024-01-01 WAS SUCCESSFULLY IMPLANTED. THE DEVICE HISTORY RECORD RELATING TO THE MANUFACTURE OF PART NUMBER 193-749, LOT 213401 WAS REVIEWED WHICH CONFIRMED THAT NO NONCONFORMING PRODUCT WAS RELEASED. THE INVESTIGATION HAS NOT IDENTIFIED A DEFINITIVE ROOT CAUSE; HOWEVER A 14MM BEARING WAS IMPLANTED WHICH COULD INFER THAT THE JOINT WAS LOOSE / UNSTABLE, BUT THIS HAS NOT BEEN STATED.

    Description of Event or Problem · 1

    "2ND REVISION CASE WAS DONE BY MR (B)(6) AT (B)(6) PRIVATE HOSPITAL (B)(6) ON WEDNESDAY, (B)(6) 2019 AND POLY WAS REPLACED. 1ST REVISION WAS DONE BY MR (B)(6) ON (B)(6) 2019 AND PATELLA WAS REPLACED." MATORTHO REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57592 SAIPH® KNEE SAIPH® FIXED TIBIAL BEARING BLUE LEFT SIZE C 12MM JWH MATOTHO LTD. 213401 05055455506701

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other