BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SIMPLEX P CEMENT 2 OF 2

    MDR report key: 8982213 · Received September 10, 2019

    Report

    Report Number
    0002249697-2019-03164
    Event Type
    Injury
    Date Received
    September 10, 2019
    Date of Event
    August 14, 2019
    Report Date
    September 10, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: AN EVENT REGARDING LOOSENING INVOLVING A UNKNOWN SIMPLEX CEMENT MIX WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT STATED THE FOLLOWING COMMENT: NEED OPERATIVE REPORTS, OFFICE/CLINICAL REPORTS, SERIAL X-RAYS, ETC. PRODUCT HISTORY REVIEW: NOT PERFORMED AS THE LOT DETAILS WERE NOT PROVIDED. COMPLAINT HISTORY REVIEW: NOT PERFORMED AS THE LOT DETAILS WERE NOT PROVIDED. CONCLUSIONS: THE REPORTED EVENT WAS NOT CONFIRMED AND THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS PRODUCT ID, OPERATIVE REPORTS, OFFICE/CLINICAL REPORTS AND SERIAL X-RAYS ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN AND LOSS OF FUNCTION. INTRA OPERATIVELY, THE FOLLOWING WAS NOTED: THE SIZE 5 CEMENTED FEMORAL COMPONENT WAS LOOSE; THERE WAS A FRACTURE AT THE JUNCTION OF THE FEMORAL STEM AND 12X100 STEM; THE CEMENTED TIBIAL COMPONENT WAS LOOSE; THE JUNCTION OF THE STEM EXTENDER AND 12X50 STEM ON THE TIBIAL SIDE WAS LOOSE. THE PATIENT'S ENTIRE TS KNEE CONSTRUCT (INCLUDING FIVE AUGMENTS) WAS REVISED TO A TRIATHLON TS KNEE CONSTRUCT WITH A CONE. REP PROVIDED ONE PAGE OF THE PRIMARY OPERATIVE REPORT, AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779306 UNKNOWN_SIMPLEX P CEMENT 2 OF 2 BONE CEMENT LOD STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R