BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 2930011 · Received January 25, 2013

    Report

    Report Number
    0002249697-2013-00282
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN FEMORL STEM. (B)(4): NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. CLINICIAN REVIEW OF THE PROVIDED MEDICAL RECORDS CONCLUDED THAT IS IT UNLIKELY THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS WERE RESPONSIBLE FOR THIS CLINICAL SITUATION. INSPECTION OF THE PROVIDED DEVICE IMAGES NOTED AN INCOMPLETE CEMENT MANTLE ON THE FLUTED PORTION OF THE STEM. THE LOCATION OF THE MISSING PORTION OF THE CEMENT MANTLE APPEARS TO CORRESPOND WITH A LUCENCY VISIBLE ON THE PROVIDED X-RAY IMAGES. THERE IS SOME TISSUE ONGROWTH NOTED ON THE BEADED PORTION OF THE STEM. VISUAL INSPECTION OF THE IMAGES IS OTHERWISE UNREMARKABLE. THE ROOT CAUSE OF THE REPORTED LOOSENING IS PRESUMED TO BE RELATED TO PATIENT FACTORS, SPECIFICALLY THE PATIENT'S EXTREME ACTIVITY LEVEL.

    Description of Event or Problem · 1

    PATIENT HAD LEFT MRS DISTAL FEMUR AND METAL ENCAPSULATED TIBIA. FEMORAL STEM IS SUSPECTED TO BE LOOSE. REVISION SURGERY IS SCHEDULED TENTATIVELY ON (B)(6), 2013.

    Description of Event or Problem · 1

    PATIENT HAD LEFT MRS DISTAL FEMUR AND METAL ENCAPSULATED TIBIA. FEMORAL STEM IS SUSPECTED TO BE LOOSE. REVISION SURGERY IS SCHEDULED TENTATIVELY ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35226 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention