BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT NECK

    MDR report key: 2850921 · Received November 20, 2012

    Report

    Report Number
    9616680-2012-01142
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 1, 2010
    Report Date
    October 25, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    KWL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED BUT BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADD¿L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAS BILATERAL HIP IMPLANTS. THE PT HAS HAD CONSTANT PAIN ON THE OUTSIDE OF THE RIGHT HIP SINCE THE (B)(6) 2011. THE PT CONSULTED HER SURGEON IN (B)(6) 2011. THE PT HAD X-RAYS AND A BONE SCAN. THE PT REPORTS DIFFICULTY SITTING OR STANDING FOR EXTENDED PERIODS OF TIME. THE PT CANNOT LIE ON THE RIGHT SIDE AND HAS BEEN SLEEPING IN A RECLINER FOR MORE THAN ONE YEAR. THE PT RECENTLY RECEIVED THE RECALL NOTIFICATION. SHE CONSULTED WITH HER SURGEON ON (B)(6) 2012. SHE IS BEING SCHEDULED FOR BLOOD WORK, A MARS MRI AND A FOLLOW-UP EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN RIGHT NECK IMPLANT KWL STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other