BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAIPH KNEE

    MDR report key: 8694874 · Received June 13, 2019

    Report

    Report Number
    3008985661-2019-00005
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    May 10, 2019
    Report Date
    October 1, 2019
    Manufacturer
    MATORTHO LIMITED
    Product Code
    JWH
    UDI-DI
    05055455506091
    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 RIGHT KNEE WAS PLANNED FOR (B)(6) 2019. NO DEVICE INVESTIGATION IS POSSIBLE AT PRESENT AS THE DEVICE REMAINS IMPLANTED, HOWEVER A REVIEW OF THE DEVICE HISTORY RECORD RELATING TO THE MANUFACTURE OF PART 193-027 LOT 216061 WAS PERFORMED WHICH CONFIRMED THAT NO NONCONFORMING PRODUCT WAS RELEASED. ON 01OCT2019: ADDITIONAL INFORMATION WAS RECEIVED ON 26SEP2019 WHICH STATED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT HAD A FALL IN A TRENCH AND AN INITIAL TKR ARTHROSCOPY DID NOT HELP THE PAIN AND SWELLING. SURGERY PERFORMED ON (B)(6) 2019 IMPLANTED A PATELLA 23MM (190-110 SAIPH CEMENTED PATELLA 23MM, LOT 214468 EXPIRY DATE 2026-01-01); NO DEVICE WAS EXPLANTED. IT WAS REPORTED THAT THE PATIENT WAS FEELING BETTER WITH NO COMPLICATIONS.

    Description of Event or Problem · 0

    A NOTIFICATION WAS RECEIVED STATING THAT A REVISION OF A RIGHT KNEE (SAIPH) WAS PLANNED FOR 08AUG2019, PER (B)(4).

    Additional Manufacturer Narrative · 1

    NOTIFICATION WAS RECEIVED THAT A SAIPH REVISION RIGHT KNEE WAS PLANNED FOR (B)(6) 2019. NO DEVICE INVESTIGATION IS POSSIBLE AT PRESENT AS THE DEVICE REMAINS IMPLANTED, HOWEVER A REVIEW OF THE DEVICE HISTORY RECORD RELATING TO THE MANUFACTURE OF PART 193-027 LOT 216061 WAS PERFORMED WHICH CONFIRMED THAT NO NONCONFORMING PRODUCT WAS RELEASED.

    Description of Event or Problem · 1

    A NOTIFICATION WAS RECEIVED THAT A REVISION OF A RIGHT KNEE (SAIPH) WAS PLANNED FOR (B)(6) 2019, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488770 SAIPH KNEE SAIPH FEMUR CEMENTED RED RIGHT SIZE 3 JWH MATORTHO LIMITED 216061 05055455506091

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other