BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FIX

    MDR report key: 3070853 · Received April 22, 2013

    Report

    Report Number
    1020279-2013-00223
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS SENT TO THE LAB FOR EVALUATION. THE PURPOSE OF THIS INVESTIGATION WAS TO EXAMINE THE AS-RECEIVED IMPLANTS. NO DESTRUCTIVE TESTING WAS CARRIED OUT. DISCOLORATION DUE TO ABSORPTION OF BIOLOGICAL FLUID WAS OBSERVED ON THE BACKSIDE OF THE LINER. BURNISHING AND LIGHT SCRATCHING WERE OBSERVED ON THE ARTICULATING SURFACE OF THE LINER. TOTAL LINEAR PENETRATION WAS ESTIMATED TO BE 2.5 MM USING SILICONE MOLD REPLICATION. SEVERAL AREAS OF DAMAGE WERE OBSERVED ON THE FACE OF THE LINER. WHILE THE MAJORITY OF THIS DAMAGE WAS LIKELY INTRODUCED DURING REVISION/EXTRACTION OF THE LINER, DAMAGE ON THE OVERHANG WAS LIKELY CAUSE BY IMPINGEMENT WITH THE FEMORAL STEM. WHITENING AND DELAMINATION, INDICATIVE OF OXIDATIVE EMBRITTLEMENT, WAS OBSERVED IN THIS AREA. THE MOST LIKELY CAUSE OF DELAMINATION WAS THE EMBRITTLED STATE OF THE UHMWPE MATERIAL OF THE LINER COMBINED WITH HIGH STRESSES. RECENT REPORTS IN CLINICAL AND SCIENTIFIC LITERATURE SUGGEST THAT THE OXIDATION WHICH OCCURS OVER TIME ON THE SHELF, POST -STERILIZATION, CAN LEAD TO MECHANICAL EMBRITTLEMENT OF UHMWPE. ALTHOUGH, THE IN VIVO OXIDATION RATE OF -STERILIZED UHMWPE IS LESS THAN THAT FROM SHELF AGING, IT CAN STILL OCCUR. THE INSERT WAS SHELF AGED FOR FROM THE 2ND QUARTER OF 1994 UNTIL JANUARY 1995, AND IN VIVO FOR APPROXIMATELY 18 YEARS. THE VISUAL APPEARANCE OF THESE FEATURES IS SIMILAR TO PREVIOUSLY RETRIEVED -STERILIZED COMPONENTS THAT HAD PERIODS OF SHELF AND IN VIVO AGING. BASED ON THE IMPLANTATION TIME AND ESTIMATED TOTAL LINEAR PENETRATION, THE YEARLY PENETRATION RATE WAS CALCULATED TO BE APPROXIMATELY 0.14 MM/YR. THIS IS WITHIN THE RANGE OF WEAR RATES REPORTED IN THE LITERATURE FOR RETRIEVED LINERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171473 OPTI-FIX FEMORAL COMPONENT JDH SMITH & NEPHEW, INC. 2D76991

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R