BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS

    MDR report key: 3781318 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01601
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K103233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING INFECTION INVOLVING A ADM LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT AND STERILE LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS RECEIVED. FURTHER INFORMATION SUCH AS RETURN OF DEVICE, PATHOLOGY REPORT, X-RAYS, PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS A KNOWN POSSIBLE ADVERSE OUTCOME OF SURGERY AND IS BEYOND STRYKER'S CONTROL.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT # 6051-0830S, LOT # MLE436, DESCRIPTION: SECUR-FIT MAX 132 HIP STEM #8; CAT # 502-03-50D, LOT # MLRR55, DESCRIPTION: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM; CAT # 626-00-38D, LOT # 40963902, DESCRIPTION: MODULAR DUAL MOBILITY INSERT; CAT # 06-2205, LOT # UNKNOWN, DESCRIPTION: C-TAPER COCR LFIT HEAD 22MM/+5; CAT # UNKNOWN, LOT # UNKNOWN, DESCRIPTION: 25MM SCREWS (QTY. 2). IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICES WERE RETAINED BY THE HOSPITAL AND NO FURTHER INFORMATION WOULD BE PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. DEVICES RETAINED BY HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS' RIGHT HIP WAS REVISED DUE TO INFECTION. THE SURGEON REMOVED ALL COMPONENTS AND AN ANTIBIOTIC SPACER WAS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS' RIGHT HIP WAS REVISED DUE TO INFECTION. THE SURGEON REMOVED ALL COMPONENTS AND AN ANTIBIOTIC SPACER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259353 RESTORATION ADM X3 INS IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH 40124701

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R