BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR-POLY LINER-36MM

    MDR report key: 5088260 · Received September 18, 2015

    Report

    Report Number
    3005985723-2015-00166
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Date of Event
    August 25, 2015
    Report Date
    August 25, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    OQG
    PMA / PMN Number
    K122158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DAMAGED THREADS INVOLVING A MAKO IMPACTOR WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: MATERIAL ANALYSIS WAS PERFORMED AND CONCLUDED THAT THE "DAMAGE WAS OBSERVED ON THE THREADS OF THE IMPACTOR, CONSISTENT WITH IMPROPER SEATING. NO MATERIALS OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED." MEDICAL RECORDS RECEIVED AND EVALUATION: NO PATIENT MEDICAL RECORDS WERE AVAILABLE FOR REVIEW. DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES COMPLAINT HISTORY REVIEW: THERE HAS BEEN (B)(4) OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE INVESTIGATION DETERMINED THE LIKELY ROOT CAUSE OF THE DAMAGE WAS DUE TO LACK OF COMPLETE SEATING OF THE STRAIGHT SHELL INSERTER SHAFT ONTO THE SHOULDER OF THE DEVICE. THERE IS NO INDICATION AT THIS TIME THAT THE DESIGN, MATERIALS, OR MANUFACTURING OF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    AT (B)(6), DURING SURGERY IT WAS NOTICED THE 112636 LOT 120233 SZ 36 LINER IMPACTOR HAD DAMAGED THREADS. SURGEON USED THE ITEM AS IS TO SUCCESSFULLY COMPLETE THE CASE.

    Description of Event or Problem · 1

    AT (B)(6) HOSPITAL, DURING SURGERY IT WAS NOTICED THE 112636 LOT 120233 SZ 36 LINER IMPACTOR HAD DAMAGED THREADS. SURGEON USED THE ITEM AS IS TO SUCCESSFULLY COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620493 IMPACTOR-POLY LINER-36MM HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, + ADDITIVE, POROUS, U OQG STRYKER ORTHOPAEDICS-MAHWAH 120233

    Patients

    Seq Age Sex Outcome Treatment
    1 Other