BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD KNEE RESECTION PROCEDURE 3 PACK

    MDR report key: 1638808 · Received March 18, 2010

    Report

    Report Number
    2950261-2010-00001
    Event Type
    Injury
    Date Received
    March 18, 2010
    Date of Event
    December 14, 2009
    Report Date
    March 9, 2010
    Manufacturer
    SYNVASIVE TECHNOLOGY, INC.
    Product Code
    GFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SALES ORDER INFORMATION SHOW SYSTEM 6 BLADE WAS ORDERED BY THE HOSPITAL AND SHIPPED CORRECTLY. THE WRONG BLADE WAS LOADED INTO THE SYSTEM 5 SAW. SYSTEM 6 SAW BLADES ARE NOT INTENDED TO BE USED ON STRYKER SYSTEM 5 SAWS. ON (B) (6) 2010, EMAIL RECEIVED FROM PHYSICIAN INDICATING THAT THE MCL HEALED UNEVENTFULLY AND PATIENT IS EXPERIENCING SOME STIFFNESS IN THE KNEE.

    Description of Event or Problem · 1

    DURING AN OXFORD PARTIAL KNEE REPLACEMENT SURGERY, A PHYSICIAN REPORTED A STRYKER SYSTEM 6 BLADE WAS USED IN A STRYKER SYSTEM 5 HANDPIECE. IT WAS REPORTED, THE BLADE WOBBLED DURING USE AND CUT AN MCL AS A RESULT. THE DOCTOR PERFORMING THE PARTIAL KNEE REPLACEMENT REPAIRED THE MCL DURING SURGERY. ON (B) (6) 2010, THE DOCTOR REPORTED THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD KNEE RESECTION PROCEDURE 3 PACK GFA SYNVASIVE TECHNOLOGY, INC. 11-3716 94120

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention