BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIFIT HFX HIP STEM SIZE #07 132

    MDR report key: 8869725 · Received August 7, 2019

    Report

    Report Number
    0002249697-2019-02765
    Event Type
    Malfunction
    Date Received
    August 7, 2019
    Date of Event
    July 11, 2019
    Report Date
    October 14, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    UDI-DI
    07613327023480
    PMA / PMN Number
    K031744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING ASSEMBLY ISSUE INVOLVING AN OMNIFIT STEM AND A METAL HEAD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: THE STEM WAS RETURNED FOR EVALUATION. DAMAGE WAS VISIBLE ON THE COLLAR, NECK AND TAPER CONSISTENT WITH IMPLANTATION AND SUBSEQUENT EXPLANTATION DAMAGE. DIMENSIONAL INSPECTION WAS PERFORMED IN THE COBALT CHROME OPERATIONS CELL IN MAHWAH . ONLY THE TAPER DIMENSIONS WERE INSPECTED AS THEY RELATED TO THE EVENT. ALL DIMENSIONS FOR THE TAPER WERE FOUND TO BE IN SPECIFICATION USING IGS 0002333 REVISION 6 AND CALIBRATED PRODUCTION GAGES. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED FOR REVIEW. -DEVICE HISTORY REVIEW: INDICATE ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSION: THE STEM WAS RETURNED FOR EVALUATION. DAMAGE WAS VISIBLE ON THE COLLAR, NECK AND TAPER CONSISTENT WITH IMPLANTATION AND SUBSEQUENT EXPLANTATION DAMAGE. DIMENSIONAL INSPECTION WAS PERFORMED IN THE COBALT CHROME OPERATIONS CELL IN MAHWAH . ONLY THE TAPER DIMENSIONS WERE INSPECTED AS THEY RELATED TO THE EVENT. ALL DIMENSIONS FOR THE TAPER WERE FOUND TO BE IN SPECIFICATION USING IGS 0002333 REVISION 6 AND CALIBRATED PRODUCTION GAUGES. FURTHER INFORMATION SUCH AS PRIMARY OPERATIVE NOTES AND PHOTOGRAPHS/VIDEO TAKEN WHEN THE ALLEGED EVENT WAS IDENTIFIED IS REQUIRED TO COMPLETE THE INVESTIGATION FOR CONFIRMING THE EVENT AND DETERMINING A ROOT CAUSE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    AS REPORTED: "SURGEON WAS PERFORMING A BIPOLAR HIP PROCEDURE¿.STEM WAS IMPLANTED¿HE ATTEMPTED TO PUT THE HEAD ON THE TRUNNION AND IT WOULD NOT LOCK ON¿..A SECOND HEAD WAS OPENED AND IT ALSO WOULD NOT LOCK¿.HE REMOVED THE STEM AND IMPLANTED A SECOND #7 HFX STEM¿.HE THEN PUT THE HEAD ON TO THE TRUNNION, IT LOCKED WITHOUT INCIDENT, HE ADDED THE BIPOLAR HEAD, AND REDUCED THE HIP". A SURGICAL DELAY OF 10 MINUTES WAS REPORTED. UPDATE (B)(6) 2019 WG: SPOKE TO REP. RIGHT HIP. THE FIRST ATTEMPTED FEMORAL HEAD WAS ULTIMATELY IMPLANTED IN THE PATIENT. THE SECOND HEAD WAS WASTED AND WILL BE RETURNED. REP WAS NOT PRESENT FOR THE PROCEDURE. REP WILL PROVIDE THE USAGE SHEET, BUT DOES NOT HAVE ACCESS TO ANY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    AS REPORTED: "SURGEON WAS PERFORMING A BIPOLAR HIP PROCEDURE¿. STEM WAS IMPLANTED¿ HE ATTEMPTED TO PUT THE HEAD ON THE TRUNNION AND IT WOULD NOT LOCK ON¿..A SECOND HEAD WAS OPENED AND IT ALSO WOULD NOT LOCK¿.HE REMOVED THE STEM AND IMPLANTED A SECOND #7 HFX STEM¿.HE THEN PUT THE HEAD ON TO THE TRUNNION, IT LOCKED WITHOUT INCIDENT, HE ADDED THE BIPOLAR HEAD, AND REDUCED THE HIP". A SURGICAL DELAY OF 10 MINUTES WAS REPORTED. UPDATE 17/JULY/2019 (B)(6): SPOKE TO REP. RIGHT HIP. THE FIRST ATTEMPTED FEMORAL HEAD WAS ULTIMATELY IMPLANTED IN THE PATIENT. THE SECOND HEAD WAS WASTED AND WILL BE RETURNED. REP WAS NOT PRESENT FOR THE PROCEDURE. USAGE SHEET WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666099 OMNIFIT HFX HIP STEM SIZE #07 132 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI STRYKER ORTHOPAEDICS-MAHWAH N789VV 07613327023480

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other