BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK RIGHT REJUVENATE/ABG II HIP

    MDR report key: 2801177 · Received October 17, 2012

    Report

    Report Number
    2249697-2012-01886
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    December 14, 2009
    Report Date
    September 27, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. AT THIS TIME, THE PT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED, HOWEVER, 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 HAD BILATERAL HIP SURGERIES ON (B)(6) 2009. SINCE THEN, PT COMPLAINS OF ON AND OFF PAIN IN BOTH HIPS. MRI AND TESTING HAVE SHOWN FLUID BUILD UP IN BOTH HIP JOINTS. THE TOXIC LIQUID HAS CAUSED THE BONE TO DETERIORATE. PT WILL UNDERGO ASPIRATION OF BOTH HIPS NEXT WEEK. HIS SURGEON HAS SCHEDULED HIM FOR REVISION SURGERY ON (B)(6) 2012 FOR BOTH HIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK RIGHT REJUVENATE/ABG II HIP IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other