BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3940936 · Received July 17, 2014

    Report

    Report Number
    0002249697-2014-02768
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN INSERT COMPONENT. ADDITIONALLY, AN UNKNOWN FEMORAL COMPONENT WAS REPORTED. AT THIS TIME, IT CANNOT BE DETERMINED WHICH, IF EITHER OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING PAIN AND A POTENTIAL MALPOSITIONED IMPLANT INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED OPERATIVE REPORT AND OFFICE NOTES WERE REVIEWED BY A CLINICAL CONSULTANT WHO DEEMED THE INFORMATION INSUFFICIENT FOR A MEDICAL DICTATION. A REVIEW OF MEDICAL RECORDS DATED (B)(6) 2014 STATES: ¿I THINK A LOT OF THE DISCOMFORT THAT SHE IS EXPERIENCING MAY BE DUE TO THE INCREASED VALGUS POSITION OF HER LIMB.¿ DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATION. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: A REVIEW OF MEDICAL RECORDS DATED (B)(6) 2014 STATES: ¿I THINK A LOT OF THE DISCOMFORT THAT SHE IS EXPERIENCING MAY BE DUE TO THE INCREASED VALGUS POSITION OF HER LIMB. I THINK THE VALGUS POSITIONING MAY BE PLACING MORE STRESS AGAINST THE MEDIAL COLLATERAL, WHICH I FOUND DIFFUSELY TENDER WHERE SHE REPORTS MOST OF HER DISCOMFORT WITH AMBULATION.¿ WHILE THE PAIN MAY BE COMING FROM MALPOSITION OF THE IMPLANTS, THIS CANNOT BE CONFIRMED AND THE ROOT CAUSE CANNOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED FOR REVIEW. FURTHER INFORMATION SUCH AS THE REVISION OPERATIVE REPORT AND X-RAYS ARE NEEDED TO COMPLETE A FULL INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS HAVING PAIN, SURGEON REVISED FEMORAL COMPONENT AND INSERT.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS HAVING PAIN, SURGEON REVISED FEMORAL COMPONENT AND INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420154 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MMREYT

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention