BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER

    MDR report key: 1071569 · Received July 9, 2008

    Report

    Report Number
    MW5007570
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 3, 2003
    Report Date
    July 2, 2008
    Manufacturer
    STRYKER
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2003, RIGHT SHOULDER ARTHROSCOPY W/BANKART REPAIR USING MULTIPLE ANCHORS AS WELL AS CAPSULE POSTERIORLY AND ANTERIORLY. WE DID PERFORM A CAPSULAR SHIFT WITH REPAIRING THE BANKART. PAIN PUMP PLACED CATHETER THROUGH THE POSTERIOR CANNULA THEN PLACED THE HUB TO THE CATHETER, PRIMED THIS, AND THEN PLACED THE ALREADY PRIMED TUBING TO THIS PAIN BUST-R CATHETER. I WAS BILLED FOR A STRYKER PAIN PUMP AND PAIN PUMP INSERTION. IN 2005, RIGHT ADHESIVE CAPSULITIS OF SHOULDER. RIGHT ARTHROSCOPY SHOULDER, LYSIS/RESECTION ADHESIONS POSSIBLE MANIPULATION, RIGHT MANIPULATION SHOULDER, FOUND RIGHT SHOULDER ARTHRITIS IN THE GLENOHUMERAL JOINT. RIGHT SHOULDER LOOSE BODIES. STRYKER TWO DAY INFUSION KIT PAIN PUMP CATHETER PLACED IN GLENOHUMERAL JOINT AND INTO SUBACROMIAL SPACE RIGHT SHOULDER. MARCAINE WITH EPINEPHRINE AND MORPHINE INJECTED INTO SPACE PRIOR TO PAIN PUMP. ON TWO AND A HALF MONTHS LATER, RIGHT SHOULDER ARTHROSCOPY - RIGHT SHOULDER DEGENERATIVE JOINT DISEASE, ARTHROFIBROSIS, PAINFUL RETAINED HARDWARE. GLENOID HAD GRADE 4 CHANGES THROUGHOUT THE ENTIRE GLENOID. GLENOID HAD GRADE 4 CHANGES WITH NO CARTILAGE REMAINING, THIS INVOLVE THE ENTIRE HUMERAL HEAD. IN 2006, PRE & POST OP DIAGNOSIS: RIGHT SHOULDER OSTEOARTHRITIS, PAIN AND MOTION LOSS. PROCEDURE(S): RIGHT SHOULDER HEMIARTHROPLASTY WITH BIOLOGICAL PLACEMENT USING AN OSTEOCHONDRAL ALLOGRAFT AND MENISCAL INTERPOSITION GRAFT. DOSE OR AMOUNT: UNK, 100 CC. FREQUENCY: UNK, 2.08CC/HR. ROUTE: 014, 014. DATES OF USE: 2003 TO 2005. DIAGNOSIS OR REASON FOR USE: RIGHT ANT LAXITY, BANKART TR, ADHESIVE CAPSULITIS OF SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER PAIN BUST-R MEB STRYKER 500-120 2005040701
    2 STRYKER STRYKER TWO DAY INFUSION KIT MEB STRYKER 500-120 2005040701500-100-705

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability 0.5% MARCAINE