BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAIPH KNEE

    MDR report key: 7946270 · Received October 9, 2018

    Report

    Report Number
    3008985661-2018-00002
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    September 17, 2018
    Report Date
    October 9, 2018
    Manufacturer
    MATORTHO
    Product Code
    JWH
    UDI-DI
    05055455506947
    PMA / PMN Number
    K140222
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAIPH REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 WHERE THE 12MM SAIPH FIXED TIBIAL BEARING (193-773) WAS REPLACED WITH AN 18 MM FIXED TIBIAL BEARING (193-776). THE 12MM BEARING HAS BEEN RETAINED BY THE FACILITY. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE HISTORY RECORD RELATING TO THE MANUFACTURE OF SAIPH FIXED TIBIAL BEARING BLUE LEFT SIZE D 12MM (193-773, LOT 202874 EXPIRY 01MAY2022) HAS BEEN REVIEWED AND DID NOT IDENTIFY ANY NON-CONFORMITIES. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAN A FURTHER REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    NOTIFICATION WAS RECEIVED STATING THAT "THE PATIENT REQUIRED REVISION KNEE SURGERY (INSERT CHANGE) POST PRIMARY TKR. PATIENT HAD A FALL 6/52 POST TKR AND RUPTURED QUADRICEPS MUSCLE. SURGEON PERFORMED AN ARTHROTOMY BUT PATIENT STILL ACHIEVING 10 DEGREES OF HYPERFLEXION. REVISION TKR WAS THEN PLANNED AND PERFORMED (B)(6) 2018, 12MM INSERT EXPLANTED, 18MM INSERTED IMPLANTED (193-776, LOT 201245)". MATORTHO REFERENCE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789572 SAIPH KNEE SAIPH FIXED TIBIAL BEARING BLUE LEFT SIZE D 12MM JWH MATORTHO 202874 05055455506947

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other