BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVON PATELLA SMALL

    MDR report key: 1921917 · Received December 6, 2010

    Report

    Report Number
    9610726-2010-00464
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    KRR
    PMA / PMN Number
    K020841
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADD'L INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR# 9610726-2010-00463.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT CALLED TO INQUIRE IF ANY OF THE IMPLANTS SHE HAS WERE SUBJECT TO RECALL. SHE HAS EXPERIENCED PAIN AND DIFFICULTY WALKING SINCE HAVING TWO SEPARATE KNEE REPLACEMENT SURGERIES. THE PT IS SCHEDULED FOR EXPLORATORY (POSSIBLE REVISION) SURGERY ON (B)(6) 2010."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVON PATELLA SMALL IMPLANT KRR STRYKER ORTHOPAEDICS LIMERICK NA LBR775

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other