BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT SER. II INSERT-10 DEG.

    MDR report key: 4844111 · Received June 15, 2015

    Report

    Report Number
    0002249697-2015-01941
    Event Type
    Injury
    Date Received
    June 15, 2015
    Date of Event
    May 19, 2015
    Report Date
    May 19, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K943054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DISLOCATION AND WEAR INVOLVING AN OMINIFIT LINER WAS REPORTED. THE EVENT COULD NOT BE CONFIRMED FOR DISLOCATION BUT WAS CONFIRMED FOR WEAR. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: A VISUAL INSPECTION WAS PERFORMED AS PART OF THE MATERIAL ANALYSIS REPORT, DATED 20 AUGUST 2015. BURNISHING AND SCRATCHES WERE OBSERVED ON THE ARTICULATING SURFACE OF THE INSERT. BURNISHING IS CAUSED BY ADHESIVE/ABRASIVE WEAR AGAINST THE V40 FEMORAL HEAD. IMPINGEMENT AND DEBRIS WAS OBSERVED ON THE OMNIFIT INSERT. EXPLANTATION DAMAGE WAS ALSO VISIBLE ON THE PROXIMAL AND DISTAL SURFACE OF THE INSERT. A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO THE DAMAGES DESCRIBED IN THE VISUAL INSPECTION. A FUNCTIONAL INSPECTION WAS NOT PERFORMED AS THE EVENT CANNOT BE REPLICATED. THE MATERIAL ANALYSIS REPORT CONCLUDED THAT: DEBRIS AND IMPINGEMENT WAS OBSERVED ON THE OMNIFIT INSERT IN ADDITION TO EXPLANTATION DAMAGE. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED. -MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT INFORMATION WAS 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 RELEVANT REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. HOWEVER NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED. FURTHER INFORMATION SUCH AS OPERATIVE REPORTS, X-RAYS, PATIENT HISTORY & FOLLOW-UP NOTES ARE NEEDED TO INVESTIGATE THIS EVENT FURTHER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    SURGEON DID A REVISION OF A (B)(6) YEAR OLD LEFT HIP DUE TO DISLOCATION. WHILE PERFORMING THE REVISION, POLY LINER SHOWED SIGNS OF WEAR - STEM AND CUP WELL FIXED AND REMAINED IMPLANTED. SURGEON EXCHANGED HEAD AND LINER.

    Description of Event or Problem · 1

    SURGEON DID A REVISION OF A 20+ YEAR OLD LEFT HIP DUE TO DISLOCATION. WHILE PERFORMING THE REVISION, POLY LINER SHOWED SIGNS OF WEAR - STEM AND CUP WELL FIXED AND REMAINED IMPLANTED. SURGEON EXCHANGED HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387513 OMNIFIT SER. II INSERT-10 DEG. IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH 23606001

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention