BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PAIN PUMP PRODUCT

    MDR report key: 2101536 · Received May 19, 2011

    Report

    Report Number
    1811755-2011-01849
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    June 8, 2000
    Report Date
    April 26, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE CATALOG NUMBER PROVIDED WAS INCOMPLETE AND THE LOT NUMBER WAS 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 FOR 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 RECEIVED A PERSONAL INJURY LAWSUIT ALLEGING THAT A PT WAS PRESCRIBED A STRYKER PAINPUMP FOLLOWING SHOULDER SURGERY ON (B)(6) 2000. SHE HAD A SECOND SHOULDER SURGERY ON (B)(6) 2008 AND IT WAS NOT INDICATED IN THE LAWSUIT IF A PAIN PUMP WAS USED. THE PT WAS DIAGNOSED WITH CHONDROLYSIS AND ALLEGES 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 MEB STRYKER INSTRUMENTS KALAMAZOO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention