BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR DUAL MOBILITY INSERT

    MDR report key: 9495516 · Received December 19, 2019

    Report

    Report Number
    0002249697-2019-04070
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    November 23, 2019
    Report Date
    December 19, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    UDI-DI
    04546540666000
    PMA / PMN Number
    K103233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: TRIDENTII HEMI CLUSTER50D; CAT#: 702-11-50D; LOT#: 66142701 6.5MM LOW PROFILE HEX SCREW 40MM; CAT#: 7030-6540; LOT#: 4VX; RESTORATION ADM X3 INS; CAT#: 1236-2-244; LOT#: 376671; 22.2MM + 3 LFIT V40 HEAD; CAT#: 6260-9-222; LOT#: 62755907; SIZE 4 ACCOLADE II 127 DEG; CAT#: 6721-0435; LOT#: 73829504. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO SUSPECTED INFECTION (IT WAS NOT REPORTED TO THE REP IF INFECTION WAS CLINICALLY CONFIRMED). THE PATIENT'S ENTIRE HIP CONSTRUCT (STEM, HEAD, ADM/ MDM LINER CONSTRUCT, SHELL SCREW) WAS REVISED TO A NEW SHELL, SCREW, POLY LINER, STEM, AND HEAD. SURGEON REPORTED THERE ARE NO ALLEGATIONS AGAINST THE REVISED IMPLANTS AND CITED A PATIENT FACTOR OF DESTRUCTIVE IV DRUG USE. REP PROVIDED THE PRIMARY AND REVISION IMPLANT REPORTS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293046 MODULAR DUAL MOBILITY INSERT PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO STRYKER ORTHOPAEDICS-MAHWAH 62251204 04546540666000

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| R