BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PAIN PUMP PRODUCT

    MDR report key: 1984505 · Received February 1, 2011

    Report

    Report Number
    1811755-2011-00295
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FRN
    PMA / PMN Number
    K042405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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/PATIENT FACTORS HAVE ALSO BEEN REPORTED AS POTENTIALLY CONTRIBUTING TO OR CAUSING CHONDROLYSIS. THE ETIOLOGY OF THE CONDITION REMAINS UNKNOWN AND BELIEVED TO BE MULTI-FACTORIAL. CURRENT LABELING FOR THIS PRODUCT ADVISES ABOUT REPORTS OF A POSSIBLE CONNECTION BETWEEN LOCAL ANESTHESICS (WITH OR W/O EPI) AND CHONDROLYSIS IN CERTAIN CIRCUMSTANCES. THE LOT NUMBER PROVIDED BY THE PATIENT DOES NOT MATCH THE LOT NUMBERING SCHEME BY STRYKER.

    Description of Event or Problem · 1

    ON OR ABOUT (B)(6) 2011, STRYKER RECEIVED A PERSONAL INJURY COMPLAINT ALLEGING THAT A PATIENT WAS PRESCRIBED A STRYKER PAINPUMP, WHICH WAS INSERTED INTO THE SUBCHROMIAL SPACE, FOLLOWING RIGHT SHOULDER SURGERY ON (B)(6) 2006. ACCORDING TO THE PATIENT, THE PUMP CAUSED SHOULDER INSTABILITY, PAIN, AND POPPING. ALTHOUGH IT WAS VERIFIED THROUGH MEDICAL RECORDS THAT A STRYKER PAIN PUMP WAS USED POST-OPERATIVELY, THERE IS NO INDICATION THAT THE PATIENT WAS DIAGNOSED WITH CHONDROLYSIS. THERE ARE NO ALLEGATIONS THE PRODUCT FAILED TO PERFORM AS DESIGNED OR PROGRAMMED BY THE PHYSICIAN. STRYKER IS UNABLE TO ASCERTAIN WHETHER OR NOT THEY WILL 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 FRN STRYKER INSTRUMENTS KALAMAZOO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other