BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAIPH KNEE

    MDR report key: 7946266 · Received October 9, 2018

    Report

    Report Number
    3008985661-2018-00001
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    June 18, 2018
    Report Date
    October 9, 2018
    Manufacturer
    MATORTHO
    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 · 1

    SAIPH IMPLANTS WERE EXPLANTED ON (B)(6) 2018 AND WERE DISPOSED OF BY THE FACILITY EXCEPT 193-736, (SAIPH FIXED TIBIAL BEARING RED LEFT SIZE C 10MM) BUT THIS HAS NOT YET BEEN RETURNED TO THE FACILITY. THE DEVICE HISTORY RECORD RELATING TO THE MANUFACTURE OF THE SAIPH IMPLANTS (190-112 LOT 216967 EXP 08/2026; 193-003 LOT 216718 EXP 08/2026; 193-602 LOT 216906 EXP 08/2026 AND 193-736 LOT 215307 EXP 03/2026) HAVE BEEN REVIEWED AND DID NOT IDENTIFY ANY NON-CONFORMITIES. WHEN FURTHER INFORMATION IS AVAILABLE AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A NOTIFICATION WAS RECEIVED AT MATORTHO LEATHERHEAD ON (B)(6) 2018 FROM MATORTHO AUSTRALIA PTY. STATING THAT A SAIPH REVISION HAD OCCURED ON (B)(6) 2018. THE PATIENT REQUIRED REVISION TOTAL KNEE ARTHROPLASTY. THE TIBIAL COMPONENT WAS LOOSE AND HAD SUBMERGED. ALL IMPLANTS WERE EXPLANTED AND AN ALTERNATIVE KNEE SYSTEM WAS REQUIRED. MATORTHO REFERENCE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786856 SAIPH KNEE SAIPH FIXED TIBIAL TRAY CEMENTED SIZE C JWH MATORTHO 216906 05055455506176

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other