BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° CROSSFIRE INSERT 26MM ID

    MDR report key: 4210951 · Received October 29, 2014

    Report

    Report Number
    0002249697-2014-04042
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K983502
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING WEAR INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION WAS PERFORMED AS PART OF THE MATERIAL ANALYSIS REPORT. "AN ALTERNATE VIEW OF THE RETURNED TRIDENT INSERT CAN BE SEEN IN FIGURE 3, WHERE SCRATCHING, BURNISHING, THIRD-BODY INDENTATION, AND DISCOLORATION ARE EVIDENT ON THE ARTICULATING SURFACE. SCRATCHING, BURNISHING, AND THIRD-BODY INDENTATIONS ARE COMMONLY IDENTIFIED DAMAGE MODES IN UHMWPE INSERTS (REFERENCE 1). THE INSERT MATERIAL HAD YELLOW DISCOLORATION, WHICH HAS BEEN ATTRIBUTED TO IN VIVO ABSORPTION OF SYNOVIAL FLUID (REFERENCE 2). EVIDENCE OF NECK IMPINGEMENT AND EXPLANTATION DAMAGE WAS OBSERVED ON THE DISTAL SURFACE OF THE INSERT (FIGURE 4). THE RIM OF THE INSERT CONTAINED MATERIAL DAMAGE DUE TO ABRASION AND DELAMINATION (FIGURE 5). DELAMINATION IS A FATIGUE-BASED MECHANISM WHICH INVOLVES CYCLIC PLASTIC DEFORMATION AND THE SUBSEQUENT REMOVAL OF LAYERS OF UHMWPE (REFERENCE 1). THE SPECIFIC CAUSE OF THIS RIM MATERIAL DAMAGE COULD NOT BE DETERMINED" THE MAR CONCLUDED: "THERE WAS NO EVIDENCE OF MANUFACTURING OR MATERIAL DEFECTS ON THE DEVICE FEATURES EXAMINED." MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS NOT PERFORMED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: A MATERIAL ANALYSIS WAS PERFORMED AND THERE WAS NO EVIDENCE OF A MANUFACTURING OR MATERIAL DEFECT ON THE EXAMINED LINER. ADDITIONAL INFORMATION INCLUDING OPERATIVE REPORTS, PROGRESS NOTES AND X-RAYS ARE HOWEVER NEEDED TO FULLY INVESTIGATE THE EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THA WAS DONE WITH TRIAD CUP, TRIDENT LINER, V40 HEAD AND EXETER STEM AT (B)(6) 2004. THE ALL IMPLANTS WERE REPLACED AT (B)(6) 2014, BECAUSE WEAR OF THE POLYETHYLENE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THA WAS DONE WITH TRIAD CUP, TRIDENT LINER, V40 HEAD AND EXETER STEM ON (B)(6) 2004. ALL IMPLANTS WERE REPLACED ON (B)(6) 2014, BECAUSE WEAR OF THE POLYETHYLENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691383 TRIDENT 0° CROSSFIRE INSERT 26MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH 06282501

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention