BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN X3 10MM INSERT

    MDR report key: 8228050 · Received January 8, 2019

    Report

    Report Number
    0002249697-2019-00096
    Event Type
    Injury
    Date Received
    January 8, 2019
    Date of Event
    October 13, 2010
    Report Date
    January 8, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION DUE INSTABILITY AFTER A TRAUMATIC POSTERIOR CRUCIATE LIGAMENT TEAR FROM A FALL INVOLVING AN UNKNOWN INSERT COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION :NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW: NOT PERFORMED AS THE DEVICE LOT NUMBER IS UNKNOWN. COMPLAINT HISTORY REVIEW: NOT PERFORMED AS THE DEVICE LOT NUMBER IS UNKNOWN. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION INCLUDING DEVICE ID AND EVALUATION, OPERATIVE REPORTS, PROGRESS NOTES, X-RAYS ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED. NOT RETURNED.

    Description of Event or Problem · 1

    AS REPORTED: "REVIEW OF SUMMARY REPORT SUBMITTED AS PART OF AN IIS MILESTONE REVEALED...DATE OF RIGHT TKA (B)(6) 2008; WAS REVISED ON (B)(6) 2010 DUE TO TRAUMATIC POSTERIOR CRUCIATE LIGAMENT TEAR FROM FALL, REVISED TO PS KNEE". UPDATE 19/DECEMBER/2018: REPORTING FACILITY CONFIRMED THERE ARE NO ALLEGATIONS AGAINST ANY STRYKER DEVICES. UPDATE 4-JAN-2018 BASED ON INFORMATION RECEIVED: FALL 2 YEARS AFTER SURGERY THAT RUPTURED HIS POSTERIOR CRUCIATE LIGAMENT AND POSTERIOR CAPSULE AND HE BECAME UNSTABLE TO ANTERIOR-POSTERIOR STRESS. WE DID NONOPERATIVE TREATMENT OF THERAPY AND BRACING AND THAT DID NOT HELP, SO IN 2010 FRK WENT BACK IN AND REVISED HIS FEMORAL COMPONENT TO A POSTERIOR STABILIZED FEMORAL COMPONENT AND WE ENDED UP WITH AN 18 MM POSTERIOR STABILIZED POLYETHYLENE TIBIAL INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18449 UNKNOWN X3 10MM INSERT KNEE IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R