BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINK(R) SPII COCR HEAD

    MDR report key: 2093355 · Received April 19, 2011

    Report

    Report Number
    9610548-2011-00011
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    February 10, 2011
    Report Date
    April 19, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JDI
    PMA / PMN Number
    K955296
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SO FAR THERE IS NO FURTHER INVESTIGATION POSSIBLE BECAUSE OF TOO LESS INFORMATION. WE ALREADY CONTACTED THE CUSTOMER TO RECEIVE MORE INFORMATION ABOUT THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    CONCLUSION: PRODUCT DID NOT CONTRIBUTE TO EVENT. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND. THE PRODUCT WAS NOT RETURNED. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.

    Description of Event or Problem · 1

    BROKEN STEM ON TIBIA COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINK(R) SPII COCR HEAD HIP COMPONENT JDI WRIGHT MEDICAL TECHNOLOGY, INC. NI 0749075

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R