BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT HIP - REJUVENATE/ABGII NECK

    MDR report key: 3601408 · Received January 13, 2014

    Report

    Report Number
    9616680-2014-00075
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    February 10, 2012
    Report Date
    December 18, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    RA 2012-067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE CATALOG AND LOT NUMBER ALONG WITH THE DEVICE WERE NOT PROVIDED FOR INVESTIGATION. THE EVENT WAS CONFIRMED. A VOLUNTARY RECALL RA 2012-67 WAS INITIATED FOR ABGII AND REJUVENATE MODULAR STEMS AND NECKS DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED EVENT IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL.

    Description of Event or Problem · 1

    IT IS REPORTED THAT: THE PT HAD A TOTAL HIP REPLACEMENT DONE ON (B)(6) 2012. AROUND (B)(6) 2012, HE NOTICED HIS PAIN WAS NOT IMPROVING. HE CONTACTED HIS SURGEON WHO SAID THAT THIS WAS NORMAL. DURING HIS VISIT TO HIS SURGEON, HE WAS INFORMED THAT HIS HIP HAD BEEN RECALLED BY STRYKER. THE PT REPORTS FEELING HELPLESS AND STATES THAT THE THOUGHT OF REVISION SURGERY SENDS HIM INTO MANIC DEPRESSION. HIS SURGEON DOES NOT THINK HE HAS THE FRETTING PROBLEM THAT INITIATED THE RECALL. HE WAS ADVISED BY HIS SURGEON TO TAKE A TWO-WEEK REST FROM THE EXERCISE REGIMEN, WHICH HE DID. HE STILL HAS THE PAIN. HE HAS ALREADY HAD AN X-RAY. HE IS SCHEDULED TO HAVE BLOOD WORK AND AN MRI. THE PT STATES THAT HIS PAIN IS AT THE IMPLANT SITE AND SOMETIMES EXTENDS TO THE FRONT OF THE HIP. HE HAS PAIN SITTING, STANDING AND WALKING FOR LONG PERIODS OF TIME; THE MORE INTENSE HIS ACTIVITY, THE MORE INTENSE THE PAIN. HE TAKES AN OVER THE COUNTER ANTI-INFLAMMATORY WHICH PROVIDES SOME RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26710 UNKNOWN RIGHT HIP - REJUVENATE/ABGII NECK IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other