BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS. HIP ENDOPROSTHESIS

    MDR report key: 4924834 · Received July 20, 2015

    Report

    Report Number
    0002249697-2015-02396
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Date of Event
    June 25, 2015
    Report Date
    June 25, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CRACK/FRACTURE INVOLVING AN EXETER CENTRALIZER WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION CONFIRMED THAT ONE OF THE THREE WINGS OF THE WINGED CENTRALISER IS BROKEN. A MATERIAL ANALYSIS REPORT CONCLUDED: ¿ONE OF THE THREE WINGS ON THE WINGED CENTRALIZER WAS BROKEN. THE LOADING WAS A LIKELY TWISTING MOTION FROM ONE SIDE OF THE WING TO THE OTHER SIDE. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED.¿ MEDICAL RECORDS RECEIVED AND EVALUATION: THERE WERE NO MEDICAL RECORDS RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. 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. CONCLUSIONS: THE SUPPLIER INVESTIGATION CONCLUDED THAT ONE OF THE THREE WINGS ON THE WINGED CENTRALIZER WAS BROKEN. THE LOADING WAS A LIKELY TWISTING MOTION FROM ONE SIDE OF THE WING TO THE OTHER SIDE. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED. THE MANUFACTURING PROCESS OF STRYKER (B)(4) AND LMO WAS REVIEWED AND NO MANUFACTURING ISSUE WAS FOUND. FURTHER REVIEW OF THE EVENT BY PACKAGING INNOVATION THAT BREAKAGE OF WING CENTRALIZER WAS LIKELY CAUSED BY MISHANDLING. PACKAGING BOM 96Z1003 USED TO PACKAGE PART NUMBER 0590-3-043 WAS ASSESSED AS FIT FOR PURPOSE. PACKAGING CONFIGURATION WAS SHIP TESTED TO STRYKER PROCEDURES AND ASTM INTERNATIONAL STANDARDS WITH SUCCESSFUL RESULTS OBTAINED NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE WING CENTRALISER WAS ALLEGEDLY BROKEN WHEN SCRUB STAFF TOOK THE DEVICE OUT THE PACKET. ANOTHER DEVICE WAS ON HAND TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES OR DELAYS TO SURGERY AS A RESULT OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE WING CENTRALISER WAS ALLEGEDLY BROKEN WHEN SCRUB STAFF TOOK THE DEVICE OUT THE PACKET. ANOTHER DEVICE WAS ON HAND TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES OR DELAYS TO SURGERY AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470227 ETS. HIP ENDOPROSTHESIS IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH G5576012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other