BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS

    MDR report key: 3678788 · Received March 14, 2014

    Report

    Report Number
    0002249697-2014-00768
    Event Type
    Injury
    Date Received
    March 14, 2014
    Date of Event
    February 17, 2014
    Report Date
    February 17, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K103233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING INFECTION INVOLVING AN ADM LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS DUE TO HOSPITAL POLICY. 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. ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT # 542-11-44C, LOT # 37038201, DESCRIPTION: TRIDENT PSL WITH PUREFIX HA . CAT # 626-00-36C, LOT # 39271503, DESCRIPTION: 6 MODULAR DUAL MOBILITY INSERT. CAT # 5096-4615, LOT # MKNA8V, DESCRIPTION: RESTORATION ACETABULAR 46MM OD X 15MM WEDGE AUGMENT. CAT # 2030-6530-1, LOT # MMM66M, DESCRIPTION: 6.5 CANCELLOUS BONE SCREW 30MM. CAT # 2030-6520-1, LOT # MLKD0L, DESCRIPTION: 6.5 CANCELLOUS BONE SCREW 20MM. CAT # 2080-0045, LOT # MKR665, DESCRIPTION: GAP PLATE SCREWS. CAT # 2080-0050, LOT # MKRL8E, DESCRIPTION: GAP PLATE SCREWS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT # 6051-0730S, LOT # MML2YJ, DESCRIPTION: SECUR-FIT MAX 132 HIP STEM #7; CAT # 06-2200, LOT # MLT79W, DESCRIPTION: C-TAPER COCR LFIT HEAD 22MM/0. 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 ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN I&D AND WASHOUT DUE TO POSSIBLE INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN I&D AND WASHOUT DUE TO POSSIBLE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153042 RESTORATION ADM X3 INS IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH 45389401

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R