BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAIPH KNEE

    MDR report key: 9150060 · Received October 3, 2019

    Report

    Report Number
    3008985661-2019-00010
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Date of Event
    June 22, 2016
    Report Date
    October 3, 2019
    Manufacturer
    MATORTHO LIMTED
    Product Code
    JWH
    UDI-DI
    05055455506121
    PMA / PMN Number
    140222
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF PATIENT (B)(6) CONFIRMED THAT PART NUMBER 193-030 SAIPH FEMUR CEMENTED BLUE RIGHT SIZE 6 (BATCH NUMBER 203044) ALONG WITH PART NUMBER 193-790 SAIPH FIXED TIBIAL BEARING BLUE RIGHT SIZE E 10MM (BATCH NUMBER 204191) AND PART NUMBER 193-604 SAIPH FIXED TIBIAL TRAY CEMENTED SIZE E (BATCH NUMBER 205992) WERE ORIGINALLY IMPLANTED IN (B)(6) 2014. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT ALL PRODUCT WAS RELEASED TO SPECIFICATION, NO NON-CONFORMING PRODUCT WAS RELEASED. A NUMBER OF FOLLOW UP REQUESTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION BUT NO INFORMATION HAS BEEN PROVIDED. IT WAS STATED THAT A COMPETITORS / ALTERNATIVE PRODUCT WAS USED DURING THE REVISION PROCEDURE. MATORTHO RECORDS CONFIRM THAT NO PRODUCT WAS SUPPLIED SPECIFICALLY FOR PATIENT (B)(6) AT THE TIME OF THE REVISION PROCEDURE. IT WAS IDENTIFIED THAT THIS REPORTABLE REVISION HAD NOT BEEN REPORTED TO THE FDA AT THE TIME WHILST REVIEWING OTHER MATORTHO NOTIFICATIONS. MATORTHO IS CORRECTING THIS OVERSIGHT.

    Description of Event or Problem · 1

    "PATIENT SPECIFIC MOULD FOR THE FEM HAD THE DISTAL BLOCK PIN HOLES IN THE WRONG POSITION CAUSING THE REST OF THE CUTTING BLOCKS TO BE MALPOSITIONED. FEM WAS RECUT TO COUNTER THE MALPOSITIONING BUT THE RESULT WAS NOT IDEAL." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945601 SAIPH KNEE SAIPH FEMUR CEMENTED BLUE RIGHT SIZE 6 JWH MATORTHO LIMTED 203044 05055455506121

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other