BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CERAMIC HEAD 12/14

    MDR report key: 5697961 · Received June 3, 2016

    Report

    Report Number
    0002249697-2016-01789
    Event Type
    Injury
    Date Received
    June 3, 2016
    Date of Event
    April 28, 2016
    Report Date
    May 6, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CRACK/FRACTURE INVOLVING AN UNKNOWN CERAMIC HEAD WAS REPORTED. THE EVENT WAS CONFIRMED FOLLOWING VISUAL INSPECTION. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION WAS PERFORMED AS PART OF THE MATERIAL ANALYSIS REPORT (MAR). THE INSPECTION NOTED: THE CERAMIC HEAD WAS FRACTURED. THE HEAD FRAGMENTS WERE EVALUATED WITH THE AID OF A STEREOMICROSCOPE AT MAGNIFICATIONS UP TO 50X. THE HEAD WAS RECONSTRUCTED. APPROXIMATELY 90% OF THE HEAD WAS RETURNED. SECONDARY CHIPPING WAS OBSERVED ON A MAJORITY OF THE FRACTURE SURFACES. THE RECONSTRUCTION SHOWS A GENERALLY LONGITUDINAL FRACTURE PATTERN. THIS TYPE OF PATTERN IS CREATED BY HOOP STRESSES GENERATED BY THE WEDGE-EFFECT OF THE STEM TRUNNION. THE FRACTURE PATTERN IS CONSISTENT WITH THE APPLICATION OF THE DEVICE. EXAMINATION OF THE MACHINED TAPERED SURFACES SHOWED WHITENING OF THE CERAMIC TAPERED. THIS WHITENED SURFACE WAS CONSISTENT WITH THE PHASE TRANSFORMATION OF THE ZIRCONIA FROM THE TETRAGONAL PHASE TO THE MONOCLINIC PHASE, AS REPORTED IN THE CLINICAL LITERATURE. THIS PHASE TRANSFORMATION CAN CAUSE INTERNAL STRESSES IN THE BASE MATERIAL. THE OBSERVED FRACTURE MORPHOLOGY IS CONSISTENT WITH AN OVERLOAD FRACTURE, WITH THE CRACK PROPAGATING OUTWARD FROM THE TAPER. THIS DIRECTION HAS BEEN VERIFIED BY THE OBSERVATION OF A FRACTURE ORIGIN ON THE FEMALE TAPER SURFACE. EXAMINATION OF THE THREE FRAGMENTS THAT MAKE UP THE MAJORITY PORTION OF THE FEMALE HEAD TAPER REVEALED A CIRCUMFERENTIAL METALLIC BAND PATTERN. THIS IS CONSISTENT WITH THE TRUNNION BEING PROPERLY SEATED IN THE TAPER. NOTHING OF NOTE WAS OBSERVED ON THE ARTICULATING SURFACE. THE MATERIAL ANALYSIS REPORT CONCLUDED: THE CERAMIC HEAD WAS FRACTURED. BASED ON THE ABOVE, THE HIGHLY STRESSED REGION OF THE CERAMIC MACHINED TAPERED SURFACE HAD UNDERGONE A PHASE TRANSFORMATION, WHICH MAY HAVE AN EFFECT ON THE STRUCTURAL INTEGRITY OF THE MATERIAL. HOWEVER, CLINICAL AND PATIENT HISTORY MAY ALSO PLAY A ROLE IN THE SURVIVORSHIP OF ANY IMPLANT. THIS SPECIFIC IMPLANT IS NO LONGER AVAILABLE FOR SALE -MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE MEDICAL RECORDS BY A CLINICAL CONSULTANT CONCLUDED: "CERAMIC HEAD FRACTURES ARE SOMETIMES CAUSED BY COMPONENT IMPINGEMENT DUE TO (CUP) MALPOSITION. THIS POTENTIAL CAUSE CANNOT BE EXCLUDED DUE TO LACK OF X-RAY INFO BUT NEITHER BE PROVED FOR THE SAME REASONS. AN INTRIGUING FACT WAS THE CUP LOOSENING. MODERN CUPS DO NOT EASILY BECOME LOOSE EXCEPT WHEN EXTERNAL OVERLOAD CONDITIONS WOULD BE PRESENT OF WHICH CUP MALPOSITION WITH IMPINGEMENT IS ONE OF THE MOST PROMINENT CAUSES FROM THE CLINICAL PERSPECTIVE. AS SUCH, IT IS NOT IMPOSSIBLE AND NOT UNLIKELY THAT BOTH THE CUP LOOSENING AND THE CERAMIC HEAD FRACTURE WOULD HAVE HAD THE SAME UNDERLYING CAUSE DUE TO EXTERNAL OVERLOAD. X-RAYS WOULD BE REQUIRED TO PROVE THIS BUT ARE UNFORTUNATELY NOT AVAILABLE FOR THIS CASE. CONSEQUENTLY, WITH THE CURRENT INFORMATION, AN EXACT ROOT CAUSE OF FAILURE CANNOT BE ESTABLISHED AND NOTHING SIGNIFICANT CAN BE ADDED TO THE CONCLUSIONS OF THE MAR REPORT. X-RAY INFO WOULD BE THE MOST IMPORTANT ADDITIONAL INFO TO HELP SOLVE THIS CASE." CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS DEVICE DETAILS, PRIMARY OPERATIVE REPORT, 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

    IT IS REPORTED BY THE NURSE OF THE HOSPITAL, THAT THE CERAMIC HEAD BROKE. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE NURSE OF THE HOSPITAL, THAT THE CERAMIC HEAD BROKE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352742 UNKNOWN CERAMIC HEAD 12/14 HIP IMPLANT KWA STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R