BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM (OSS) RS FEMORAL BUSHINGS SET ARCOM

    MDR report key: 6143037 · Received December 2, 2016

    Report

    Report Number
    0001825034-2016-05026
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    November 3, 2016
    Report Date
    February 24, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KRO
    PMA / PMN Number
    PK021260
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    -PRODUCT WAS NOT RETURNED SO NO PRODUCT EVALUATION COULD BE CONDUCTED. -REVIEW OF STERILIZATION CERTIFICATION CONFIRMS THE DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. -THIS DEVICE IS USED FOR TREATMENT. -THE COMPLAINT COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. -ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. CONCOMITANT MEDICAL PRODUCTS ¿OSS POLY BUMPER LOCK PIN CATALOG 150510 LOT 014090; OSS REINFORCED YOKE CATALOG 150493 LOT 220000; OSS TIBIAL POLY BEARING 20 MM CATALOG 150414 LOT 093360; OSS RS POLY FEMORAL BUSHINGS SET ¿ 2 CATALOG 161034 LOT 648910; OSS POLY TIBIAL BUSHING CATALOG 150476 LOT 324660.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. (B)(4). THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, ¿EARLY OR LATE POSTOPERATIVE INFECTION AND/OR ALLERGIC REACTION.¿ THIS REPORT IS NUMBER 4 OF 8 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-05023 / 1825034-2016-05030).

    Description of Event or Problem · 1

    PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE APPROXIMATELY SEVEN WEEKS POST IMPLANTATION DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791805 ORTHOPEDIC SALVAGE SYSTEM (OSS) RS FEMORAL BUSHINGS SET ARCOM PROSTHESIS, KNEE KRO BIOMET ORTHOPEDICS N/A 648910

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R