BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3002695 · Received March 13, 2013

    Report

    Report Number
    0002249697-2013-00977
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    August 30, 2011
    Report Date
    February 18, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN LEFT STRYKER KNEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INSTABILITY AND REDUCED ROM INVOLVING AN UNKNOWN INSERT WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE FOLLOW UP NOTES CONFIRM THE REPORTED EVENT. HOWEVER, THE PROVIDED INFORMATION WAS REVIEWED BY A CONSULTING CLINICIAN, DEEMING IT INSUFFICIENT FOR A FULL EVALUATION. DEVICE HISTORY REVIEW: REVIEW COULD NOT BE PERFORMED AS THE DEVICE WAS NOT PROPERLY IDENTIFIED. COMPLAINT HISTORY REVIEW: REVIEW COULD NOT BE PERFORMED AS THE DEVICE WAS NOT PROPERLY IDENTIFIED. CONCLUSIONS: NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. THE FOLLOWING PRODUCT WAS ADDED TO THE COMPLAINT AFTER THE INITIAL MEDWATCH WAS SUBMITTED. AT THIS TIME, IT CANNOT BE DETERMINED IF THIS DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S EXPERIENCE. CAT. NO.: 5520B500, TRIATHLON PRIM CEM FXD BPLT #5, LOT CODE: S4NEP; CAT. NO.: 5510F501, TRIATHLON CR FEM COMP #5 L-CEM, LOT CODE: S4FPM; CAT. NO.: 5550-G-339, TRIATHLON SYMMETRIC X3 PATELLA, LOT CODE: JL0T.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS SEVERE PAIN. KNEE POPS, CRACKS, AND DOES NOT "BEND STRAIGHT."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS SEVERE PAIN. KNEE POPS, CRACKS, AND DOES NOT "BEND STRAIGHT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104702 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other