BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT ALUMINA INSERT

    MDR report key: 4221666 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04123
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    May 16, 2014
    Report Date
    October 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MRA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CERAMIC FRACTURE INVOLVING A TRIDENT CERAMIC LINER WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION WAS PERFORMED AS PART OF THE MATERIAL ANALYSIS REPORT (MAR), DATED 10 NOV 2014. THE CERAMIC INSERT WAS FRACTURED AROUND APPROXIMATELY 100º OF THE DISTAL RIM AND REMAINED ENGAGED IN THE SLEEVE. NONE OF THE RIM FRAGMENTS WERE RETURNED. VISUAL ANALYSIS WAS PERFORMED WITH THE AID OF A STEREOMICROSCOPE AT MAGNIFICATIONS UP TO 50X. SECONDARY CRACKING AND EDGE CHIPPING DAMAGED ALL PRIMARY FRACTURE SURFACES. NO FRACTURE ORIGIN COULD BE IDENTIFIED. A VISIBLE WEAR SCAR WAS OBSERVED IN THE REGION OF FRACTURE AND EVIDENCE OF NECK IMPINGEMENT WAS OBSERVED ON THE SLEEVE. THE MAR REPORT CONCLUDED: THE FRACTURE SURFACE OF THE CERAMIC INSERT WAS DAMAGED BY SECONDARY CRACKING AND EDGE CHIPPING, PREVENTING EVALUATION OF CONDITIONS AT THE FRACTURE ORIGIN. EVIDENCE OF NECK IMPINGEMENT WAS OBSERVED ON THE INSERT SLEEVE. WEAR SCARS WERE OBSERVED ON THE ARTICULATING SURFACES OF THE HEAD AND INSERT. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE FEATURES EVALUATED. -MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT CONCLUDED THAT THE EVENT WAS MOST LIKELY DUE TO MALPOSITION OF DEVICES BUT THE EXACT NATURE OF THE MALPOSITIONING COULD NOT BE DETERMINED AS INSUFFICIENT INFORMATION WAS PROVIDED. -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 EXACT CAUSE OF THE EVENT WAS MOST LIKELY MALPOSITION OF DEVICES BUT THE EXACT NATURE OF THE MALPOSITIONING COULD NOT BE DETERMINED AS INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS X-RAYS, PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE DISTRIBUTOR (B)(4), REPORTED THE FOLLOWING EVENT: " FRACTURE OF A TRIDENT CERAMIC INSERT." REVISION SURGERY WAS PERFORMED ON (B)(6) 2014 TO CHANGE THE INSERT AND CUP. STEM AND NECK WERE NOT REVISED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR (B)(4), REPORTED THE FOLLOWING EVENT :" FRACTURE OF A TRIDENT CERAMIC INSERT." REVISION SURGERY WAS PERFORMED ON (B)(6) 2014 TO CHANGE THE INSERT AND CUP. STEM AND NECK WERE NOT REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702367 TRIDENT ALUMINA INSERT IMPLANT MRA STRYKER ORTHOPAEDICS-MAHWAH 33386801

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention