BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT HFX HIP STEM SIZE #11 132

    MDR report key: 2977053 · Received February 25, 2013

    Report

    Report Number
    0002249697-2013-00763
    Event Type
    Injury
    Date Received
    February 25, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K031744
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A PERIPROSTHETIC FRACTURE, STEM SUBSIDENCE, AND DISLOCATION INVOLVING A OMNIFIT HFX HIP STEM SIZE #11 132 WAS REPORTED. THE SUBSIDENCE WAS CONFIRMED. THE PERIPROSTHETIC FRACTURE AND DISLOCATION WERE NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO DEVICE WAS RETURNED. A REVIEW OF THE PROVIDED X-RAYS BY A CLINICAL CONSULTANT CONFIRMED STEM SUBSIDENCE. ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINISHED GOODS WITH NO REPORTED DISCREPANCIES. NO SIMILAR EVENTS WERE REPORTED FOR THE LOT NUMBER. THE ROOT CAUSE OF THE PERIPROSTHETIC FRACTURE, STEM SUBSIDENCE, AND DISLOCATION COULD NOT BE DETERMINED BECAUSE OF A LACK OF INFORMATION. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED, FURTHER INFORMATION IS NEEDED.

    Description of Event or Problem · 1

    DR. (B)(6) DID A FRACTURE HEMIARTHROPLASTY USING THE OMNIFIT HFX SYSTEM. HE BROACHED AND PUT IN A SIZE 11 PRESS FIT OMNIFIT HFX STEM. TRIALED THE HEAD AND BIPOLAR AND ASKED FOR THE IMPLANTS. OMNIFIT HFX SIZE 11, + 0 28MM C-TAPER HEAD AND UHR SIZE 53. ALL PARTS IMPLANTED AND SURGEON FINISHED THE SURGERY. APPROXIMATELY 2 HRS LATER, I RECEIVED A CALL FROM THE SURGEON STATING, THE IMPLANT HAD SUBSIDED AND WAS DISLOCATING IN THE RECOVERY ROOM. HE TOOK THE PATIENT BACK INTO SURGERY AFTER I RETURNED. HE REMOVED THE STEM AND ADDED A CENTRALIZER AND RECEMENTED THE STEM. HE CHANGED THE HEAD TO A LONG HEAD AND REPLACED THE BIPOLAR IMPLANT. DR. (B)(6) TOOK AN X-RAY INTRAOPERATIVELY AND NOTICED A MID SHAFT FRACTURE ABOVE THE CEMENTED STEM. HE APPLIED 2 LUKKI WIRES AND CLOSED HE PATIENT. POST OP X-RAYS IN RECOVERY ROOM WERE TAKEN AND SURGEON WAS HAPPY WITH RESULTS.

    Description of Event or Problem · 1

    DR (B)(6) DID A FRACTURE HEMIARTHROPLASTY USING THE OMNIFIT HFX SYSTEM. HE BROACHED AND PUT IN A SIZE 11 PRESS FIT OMNIFIT HFX STEM. TRIALED THE HEAD AND BIPOLAR AND ASKED FOR THE IMPLANTS. OMNIFIT HFX SIZE 11, + 0 28MM C-TAPER HEAD AND UHR SIZE 53. ALL PARTS IMPLANTED AND SURGEON FINISHED THE SURGERY. APPROXIMATELY 2 HRS LATER I RECEIVED A CALL FROM THE SURGEON STATING THE IMPLANT HAD SUBSIDED AND WAS DISLOCATING IN THE RECOVERY ROOM. HE TOOK THE PATIENT BACK INTO SURGERY AFTER I RETURNED. HE REMOVED THE STEM AND ADDED A CENTRALIZER AND RECEMENTED THE STEM. HE CHANGED THE HEAD TO A LONG HEAD AND REPLACED THE BIPOLAR IMPLANT. DR (B)(6) TOOK AN X-RAY INTRAOPERATIVELY AND NOTICED A MID SHAFT FRACTURE ABOVE THE CEMENTED STEM. HE APPLIED 2 LUKKI WIRES AND CLOSED THE PATIENT. POST OP X-RAYS IN RECOVERY ROOM WERE TAKEN AND SURGEON WAS HAPPY WITH RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79839 OMNIFIT HFX HIP STEM SIZE #11 132 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH KE3MKE

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention