BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_INSTRUMENTS_PRODUCT

    MDR report key: 3253778 · Received July 30, 2013

    Report

    Report Number
    0001811755-2013-01790
    Event Type
    Injury
    Date Received
    July 30, 2013
    Date of Event
    October 20, 2006
    Report Date
    July 15, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 INFORMATION ON THE DEVICE USED. THERE IS NO ALLEGED FAILURE OF THE PUMP AND THE DEVICE HAS NOT BEEN RETURNED FOR EVAL. DESIGN, MECH, 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 DEV OF CHONDROLYSIS. ALTHOUGH THERE IS NO RANDOMIZED CLIN DATA ASSOCIATED WITH THE USE OF LOCAL ANESTHETICS (WITH OR W/O EPI) AND THE DEV OF CHONDROLYSIS, RECENT CASE REPORTS, ANIMAL, AND IN-VITRO STUDIES SUGGEST A POSSIBLE CONNECTION. THE USE OF THERMAL/RF DEVICES, VARIOUS DYES AND SOLNS, MECH INJURY TO CARTILAGE, OSMOLARITY, BIODEGRADABLE SUTURES, SUB-CLINICAL INFECTION, AGE, SURG 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 ANESTHETICS (WITH OR W/O EPI) AND CHONDROLYSIS IN CERTAIN CIRCUMSTANCES.

    Description of Event or Problem · 1

    ON OR ABOUT (B)(4) 2013, STRYKER RECEIVED A PERSONAL INJURY LAWSUIT ALLEGING THAT A PATIENT WAS PRESCRIBED A STRYKER PAIN PUMP FOLLOWING SHOULDER SURGERY ON (B)(6) 2006 AT (B)(6) MEDICAL CENTER IN (B)(6). ON (B)(6) 2013 THE PATIENT HAD A JOINT DEBRIDEMENT AT (B)(6) MEDICAL CENTER IN (B)(6). THE PATIENT 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
    356419 UNKNOWN_INSTRUMENTS_PRODUCT PUMP, INFUSION FRN STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R