BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER. FEMORAL STEM + 2 PMMA CENTRALISERS 35.5MM

    MDR report key: 3201971 · Received July 2, 2013

    Report

    Report Number
    0002249697-2013-02201
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 10, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K891454
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING STEM FRACTURE INVOLVING AN EXETER DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. VISUAL INSPECTION SHOWED THAT THE EXETER STEM IS BROKEN APPROXIMATELY 87MM FROM THE DISTAL TIP OF THE STEM. THE FEMORAL HEAD IS STILL ATTACHED TO THE TRUNNION. THERE ARE SOME MARKS OF USE ON THE DEVICE AND FRETTING CORROSION. THE FRACTURE SEEMS TO OCCURRED IN TWO TIMES BECAUSE THERE IS A STEP ON THE FRACTURE SITE. THE MATERIAL ANALYSIS REVIEW INDICATED THAT THE FRACTURE ORIGINATED ON THE LATERAL SIDE OF THE DEVICE AND PROPAGATED MEDIALLY; ALTHOUGH, THE ORIGIN AND FINAL FRACTURE REGIONS WERE OBSCURED BY POST-FRACTURE ABRASION. THERE WAS EVIDENCE OF FRETTING AND CORROSION PRODUCTS ON THE MEDIAL SIDE OF THE RETURNED STEM MOST LIKELY DUE TO MICRO-MOTION BETWEEN THE STEM AND THE CEMENT MANTLE. NO DEFECTS OR DAMAGES THAT MAY HAVE INITIATED THE FRACTURE WERE OBSERVED. THERE WAS NO EVIDENCE OF IMPINGEMENT OBSERVED ON THE DEVICE. THE STEM MATERIAL WAS CONSISTENT WITH THE ASTM F1586 AND ISO 5832-9 ALLOY. NO MATERIAL OR MANUFACTURING DEFECTS WERE SEEN ON THE PARTS EXAMINED. DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. A REVIEW OF THE COMPLAINT HISTORY DATABASE SHOWS THAT THERE HAVE BEEN 2 OTHER RELATED PIS FOR THIS PATIENT RELATED TO PREVIOUS REVISION SURGERIES. THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE OF THE FAILURE AS PER THE CLINICAL REVIEW IS THE OVERLOAD CONDITION ACROSS THE LEFT HIP ARTHROPLASTY AS CAUSED BY A LATERAL (OR HARDINGE) APPROACH TO THE LEFT HIP JOINT MOST PROBABLY DURING THE LEFT CUP REVISION PROCEDURE IN 2002 WHILE LEAVING THE STEM IN PLACE. NO EVIDENCE FOR PATIENT-RELATED FACTORS, OR DEVICE RELATED FACTORS PLAYING ANY ROLE AS FURTHER SUPPORTED BY THE EXPLANT MATERIALS ANALYSIS. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    THE SURGEON REPORTED TO THE SALES REP THAT HE HAD TO REVISE A BROKEN EXETER STEM.

    Description of Event or Problem · 1

    THE SURGEON REPORTED TO THE SALES REP THAT HE HAD TO REVISE A BROKEN EXETER STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302578 EXETER. FEMORAL STEM + 2 PMMA CENTRALISERS 35.5MM IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH S234795

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R