BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAIPH KNEE

    MDR report key: 8478302 · Received April 3, 2019

    Report

    Report Number
    3008985661-2019-00003
    Event Type
    Malfunction
    Date Received
    April 3, 2019
    Date of Event
    March 27, 2019
    Report Date
    May 1, 2019
    Manufacturer
    MATORTHO LIMITED
    Product Code
    JWH
    UDI-DI
    05055455509351
    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 PATELLA REVISION LEFT KNEE WAS PLANNED FOR (B)(6) 2019. ADDITIONAL INFORMATION WAS REQUESTED ON (B)(6) 2019 AND (B)(6) 2019. ON (B)(6) 2019 IT WAS CONFIRMED THAT THE 30MM PATELLA HAD BEEN EXPLANTED AND A 26MM PATELLA 190-111 LOT 214300 (EXP DATE (B)(6) 2025) HAD BEEN SUCCESSFULLY IMPLANTED. THE DEVICE HISTORY RECORD RELATING TO THE MANUFACTURE OF PART 190-112 LOT 216967 WAS PERFORMED WHICH CONFIRMED THAT NO NONCONFORMING PRODUCT WAS RELEASED.

    Description of Event or Problem · 0

    A NOTIFICATION WAS RECEIVED THAT A PATELLA REVISION LEFT KNEE (SAIPH) WAS PLANNED FOR (B)(6) 2019. (B)(4).

    Additional Manufacturer Narrative · 1

    NOTIFICATION WAS RECEIVED THAT A SAIPH PATELLA REVISION LEFT KNEE WAS PLANNED FOR (B)(6) 2019. ADDITIONAL INFORMATION WAS REQUESTED ON (B)(6) 2019. ON (B)(6) 2019 IT WAS CONFIRMED THAT THE 30MM PATELLA HAD BEEN EXPLANTED AND A 26MM PATELLA 190-111, LOT 214300 (EXP DATE 2025-11-01) HAD BEEN SUCCESSFULLY IMPLANTED. THE DEVICE HISTORY RECORD RELATING TO THE MANUFACTURE OF PART 190-112, LOT 216967 WAS PERFORMED WHICH CONFIRMED THAT NO NON-CONFORMING PRODUCT WAS RELEASED.

    Description of Event or Problem · 1

    A NOTIFICATION WAS RECEIVED THAT A PATELLA REVISION LEFT KNEE (SAIPH) WAS PLANNED FOR (B)(6) 2019. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270947 SAIPH KNEE SAIPH CEMENTED PATELLA 30MM JWH MATORTHO LIMITED 216967 05055455509351

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other