BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 7000 STANDARD TIBIA

    MDR report key: 3870538 · Received June 12, 2014

    Report

    Report Number
    0002249697-2014-02217
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    January 1, 2013
    Report Date
    May 20, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K910990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICES WERE RETAINED AT (B)(6). ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING LOOSENING INVOLVING A SERIES 7000 STANDARD TIBIA WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT MEDICAL RECORDS WERE PROVIDED FOR REVIEW. DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW CONFIRMED NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE OF A LACK OF INFORMATION. FURTHER INFORMATION SUCH AS THE REPORTED DEVICE, OPERATIVE REPORTS, MEDICAL RECORDS, AND PROGRESS NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO LOOSENING. THE COMPONENTS WERE IMPLANTED IN SITU FOR ~ 6.5 Y. THE TIBIAL, FEMORAL AND PATELLAR COMPONENTS WERE REVISED. THE PATIENT PRESENTED WITH A UCLA SCORE OF 1 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM SCORE OF 3.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO LOOSENING. THE COMPONENTS WERE IMPLANTED IN SITU FOR ~ 6.5 Y. THE TIBIAL, FEMORAL AND PATELLAR COMPONENTS WERE REVISED. THE PATIENT PRESENTED WITH A UCLA SCORE OF 1 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM SCORE OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348481 SERIES 7000 STANDARD TIBIA IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH 0RNMAD

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention