BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PAIN PUMP PRODUCT

    MDR report key: 2111792 · Received May 25, 2011

    Report

    Report Number
    1811755-2011-01916
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 9, 2008
    Report Date
    May 6, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE CATALOG NUMBER AND LOT NUMBER WERE NOT PROVIDED. THE 510(K) CANNOT BE IDENTIFIED WITHOUT INFO ON THE DEVICE USED. THERE IS NO ALLEGED FAILURE OF THE PUMP AND THE DEVICE HAS NOT BEEN RETURNED FROM EVAL. DESIGN, MECHANICAL, AND MFG ELEMENTS RELATING TO THE FUNCTION OF THE PUMP CANNOT BE DETERMINED. NO DATA PRESENTLY SUGGESTS A DIRECT LINK BETWEEN ANY INHERENT ASPECT OR FEATURE OF THE PUMP AND THE DEVELOPMENT OF CHONDROLYSIS. ALTHOUGH, THERE IS NO RANDOMIZED CLINICAL DATA ASSOCIATED WITH THE USE OF LOCAL ANESTHETICS (WITH OR W/O EPI) AND THE DEVELOPMENT OF CHONDROLYSIS, RECENT CASE REPORTS, ANIMAL, AND IN-VITRO STUDIES SUGGEST A POSSIBLE CONNECTION. THE USE OF THERMAL/RF DEVICES, VARIOUS DYES AND SOLUTIONS, MECHANICAL INJURY TO CARTILAGE, OSMOLARITY, BIODEGRADABLE SUTURES, SUB-CLINICAL INFECTION, AGE, SURGICAL INTERVENTION, OVER TIGHTENED JOINTS AND VARIOUS OTHER PHYSICIAN/PT FACTORS HAVE ALSO BEEN REPORTED AS POTENTIALLY CONTRIBUTING TO OR CAUSING CHONDROLYSIS. THE ETIOLOGY OF THE CONDITION REMAINS UNK AND BELIEVED TO BE MULTI-FACTORIAL. CURRENT LABELING FOR THIS PRODUCT ADVISES ABOUT REPORTS OF A POSSIBLE CONNECTION BETWEEN LOCAL ANESTHETICS (WITH OR W/O EPI) AND CHONDROLYSIS IN CERTAIN CIRCUMSTANCES.

    Description of Event or Problem · 1

    ON OR ABOUT (B)(6) 2011, STRYKER REC'D A PERSONAL INJURY LAWSUIT ALLEGING THAT A PT WAS PRESCRIBED A STRYKER PAINPUMP FOLLOWING RIGHT SHOULDER SURGERY IN (B)(6) ON (B)(6) 2008. THE PT IS ALLEGING CHONDROLYSIS AND FEELS THAT THE CHONDROLYSIS IS A RESULT OF THE CONTINUED INJECTION OF MEDICATION INTO THEIR SHOULDER. THERE ARE NO ALLEGATIONS THE PRODUCT FAILED TO PERFORM AS DESIGNED OR PROGRAMMED BY THE PHYSICIAN. STRYKER IS UNABLE TO ASCERTAIN WHETHER OR NOT ONE OF ITS PRODUCTS WAS ACTUALLY USED AND WILL NOT BE ABLE TO OBTAIN THE PRODUCT EXCEPT WITHIN THE LITIGATION PROCESS, IF AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PAIN PUMP PRODUCT INFUSION PUMP MEB STRYKER INSTRUMENTS KALAMAZOO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention