BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) ALL-POLY TRI-PEG ONLAY PATELLA

    MDR report key: 7541238 · Received May 24, 2018

    Report

    Report Number
    3010536692-2018-00718
    Event Type
    Injury
    Date Received
    May 24, 2018
    Report Date
    May 24, 2018
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JWH
    PMA / PMN Number
    K953439
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WILL BE UPDATED ONCE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM NJR: UPDATED INCIDENT DESCRIPTION AND EVENT PROBLEM AND EVALUATION CODES AND EXPLANT DATE.

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY. REVISION NJR NUMBER: (B)(4). SIDE:L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON 11/08/2018 FROM NJR:. ALLEGEDLY, PATIENT WAS REVISED DUE TO MALALIGNMENT. REVISION NJR (B)(4). SIDE:L: PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. UPDATED THE REASON FOR REVISION, EXPLANT DATE ((B)(6)2016), NJR # (B)(4). THE FOLLOWING COMPONENTS HAVE NO ALLEGED DEFICIENCY AND WERE NOT REVISED DURING THIS SURGERY. (THIS REVISION WAS CAPTURED UNDER: (B)(4)) ADVANCE PRIMARY FEMORAL SIZE 2 LEFT NONPOROUS KFTCNP2L LOT # 06484773 QTY. 1. ADVANCE II COCR TIBIA BASE NONPOROUS SZ 2+ KTCCNP21 LOT # 06484773 QTY. 1. ADVANCE II MEDIAL PIVOT TIBIA INSERT SZ 2 LEFT 10MM KIMP210L LOT # 05486956 QTY. 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385496 ADVANCE(R) ALL-POLY TRI-PEG ONLAY PATELLA KNEE COMPONENT JWH MICROPORT ORTHOPEDICS INC. KPON-TP35 01467232

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention