BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALUMINA C-TAPER HEAD 28MM/-2.5

    MDR report key: 4140316 · Received October 3, 2014

    Report

    Report Number
    0002249697-2014-03741
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    August 26, 2014
    Report Date
    April 24, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K003391
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A FRACTURED CERAMIC HEAD INVOLVING AN ALUMINA C-TAPER HEAD 28MM/-2.5 WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION WAS PERFORMED AS PART OF THE MATERIAL ANALYSIS REPORT (MAR). "THE CERAMIC HEAD AND FRAGMENTS WERE RETURNED. BASED ON A VISUAL INSPECTION OF THE RETURNED FRAGMENTS, APPROXIMATELY 80% OF THE HEAD WAS RETURNED FOR ANALYSIS. THE DEVICES WERE EVALUATED WITH THE AID OF A STEREOMICROSCOPE AT MAGNIFICATIONS UP TO 50X. THE LOCATION OF THE FRACTURE ORIGIN COULD NOT BE DETERMINED DUE TO POST-FRACTURE ABRASION ON THE FRACTURE SURFACES. A CONTINUOUS METAL TRANSFER MARKING WAS NOT OBSERVED ACROSS ALL RETURNED FRAGMENTS. THIS IS A LIKELY INDICATION THAT THE TRUNNION WAS NOT PROPERLY SEATED IN THE TAPER. IF THERE WAS A DISCONTINUOUS METAL TRANSFER PATTERN, UPON LOADING, A DISCONTINUOUS CONTACT PATTERN MAY CAUSE LOCALIZED ELEVATED STRESS LEVELS WITHIN THE ALUMINA HEAD, LEADING TO BREAKAGE."THE MAR CONCLUDED THAT ""NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE FEATURES EXAMINED" MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED FOR REVIEW. 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 CONCLUDED THAT "NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE FEATURES EXAMINED". THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED HOWEVER BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PROGRESS NOTES AND X-RAYS ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE THIS INVESTIGATION WILL BE RE-OPENED. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A FRACTURED CERAMIC HEAD INVOLVING AN ALUMINA C-TAPER HEAD 28MM/-2.5 WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW CONFIRMED NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE OF A LACK OF INFORMATION. FURTHER INFORMATION SUCH AS THE REPORTED DEVICE, MEDICAL RECORDS, AND X-RAYS ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ACCORDING TO THE SALES REP, THE SURGEON NOTIFIED HIM THAT ONE OF HIS PATIENTS, WHO HAD A HIP SURGERY IN (B)(6) 2008, HAD THE CERAMIC HEAD 17-28-3E BROKEN IN SEVERAL PIECES. THE SURGEON COULD SEE THIS BECAUSE OF THE X-RAY. BECAUSE OF THIS, THE SURGEON MADE A REVISION SURGERY TO REMOVE THESE PIECES FROM THE PATIENT. IMPLANTS FROM OTHER COMPANY WERE IMPLANTED TO THE PATIENT. THE SURGEON WANTS TO KNOW WHAT HAPPENED.

    Description of Event or Problem · 1

    ACCORDING TO THE SALES REP, THE SURGEON NOTIFIED HIM THAT ONE OF HIS PATIENTS, WHO HAD A HIP SURGERY IN (B)(6) OF 2008, HAD THE CERAMIC HEAD 17-28-3E BROKEN IN SEVERAL PIECES. THE SURGEON COULD SEE THIS BECAUSE OF THE X-RAY. BECAUSE OF THIS, THE SURGEON MADE A REVISION SURGERY TO REMOVE THESE PIECES FROM THE PATIENT. IMPLANTS FROM OTHER COMPANY WERE IMPLANTED TO THE PATIENT. THE SURGEON WANTS TO KNOW WHAT HAPPENED.

    Description of Event or Problem · 1

    ACCORDING TO THE SALES REP, THE SURGEON NOTIFIED HIM THAT ONE OF HIS PATIENTS, WHO HAD A HIP SURGERY IN (B)(6) 2008, HAD THE CERAMIC HEAD (B)(4) BROKEN IN SEVERAL PIECES. THE SURGEON COULD SEE THIS BECAUSE OF THE X-RAY. BECAUSE OF THIS, THE SURGEON MADE A REVISION SURGERY TO REMOVE THESE PIECES FROM THE PATIENT. IMPLANTS FROM OTHER COMPANY WERE IMPLANTED TO THE PATIENT. THE SURGEON WANTS TO KNOW WHAT HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619085 ALUMINA C-TAPER HEAD 28MM/-2.5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO STRYKER ORTHOPAEDICS-MAHWAH 17159201

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention