BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 0DEG 30MM

    MDR report key: 2669189 · Received July 12, 2012

    Report

    Report Number
    9616680-2012-00518
    Event Type
    Injury
    Date Received
    July 12, 2012
    Date of Event
    May 15, 2012
    Report Date
    June 19, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICES CANNOT BE PERFORMED AS THE DEVICES WERE RETAINED BY THE HOSPITAL AND WERE NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME EVENT AS MFR # 2249697-2012-00699. (B)(4). ADDITIONAL INFORMATION FROM THE USER FACILITY REPORT: PT IDENTIFIER: (B)(6), DATE OF REPORT: (B)(4) 2012, BRAND NAME: REJUVENATE, COMMON DEVICE NAME: MODULAR NECK, MFR NAME AND ADDRESS: STRYKER ORTHOPEDICS, (B)(4), OTHER#: 127/132 0 30 MM, DEVICE AVAILABLE FOR EVAL: YES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, PATIENT HAS PERSISTENT HIP PAIN. ADDITIONAL INFORMATION PROVIDED IN THE USER FACILITY REPORT RECEIVED (B)(4) 2012: (B)(6) FEMALE UNDERWENT RTHR REVISION (B)(6) 2012, S/P (B)(6) 2011, RTHR FOR OA W/ STRYKER REJUVENATE COMPONENTS. THE PT WAS DOING WELL UNTIL SHE DEVELOPED GROIN PAIN IN (B)(6) 2011. ON (B)(6) 2012, SHE RECEIVED AN US-GUIDED R ILIOPSOAS BURSA INJECTION. THE US SHOWED MODERATE ILIOPSOAS TENDINOSAS. THE PT UNDERWENT R HIP MRI ON (B)(6) 2012, FOR TENDINOSIS AND CONCERN W/ IMPLANT LOOSENING ON (B)(6) 2012, SERUM CHROMIUM < 1.0 (REF <5.0) WAS NOT ELEVATED. HOWEVER, SERUM COBALT WAS ELEVATED, 28.0 (REF <1.0). R HIP SYNOVIAL US-GUIDED ASPIRATION/BIOPSY ON (B)(6) 2012, NOTED FINDINGS CONSISTENT W/ IMMUNOLOGICALLY MEDIATED REACTION TO PARTICULATE MATERIAL CONSISTENT W/CORROSION PRODUCTS. REACTION IS PREDOMINANTLY GRANULOMATOUS. THE (B)(6) 2012, REVISION WAS PERFORMED WITHOUT COMPLICATION. HISTOPATHOLOGY FINDINGS ARE CONSISTENT W/ A GRANULOMATOUS IMMUNOLOGICALLY MEDIATED REACTION TO IMPLANT MATERIAL, CONSISTENT W/ CORROSION PRODUCTS. ALVAL SCORE IS 6/10 (SYNOVIAL LING 2, INFLAMMATORY INFILTRATE 3, TISSUE ORGANIZATION 1). FINDINGS ARE SIMILAR TO THOSE OF FINE NEEDLE BIOPSY OF (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LRG TAP PRI MOD NCK 0DEG 30MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NLS300000B 36763601

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| O| R STRYKER REJUVENATE TMZF SIZE 7 MODULAR STEM:| (B)(4), LOT# MKJPY1 (SEPARATE MEDWATCH)