BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UHR BIPOLAR 28X53MM

    MDR report key: 2977022 · Received February 25, 2013

    Report

    Report Number
    0002249697-2013-00762
    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
    KWL
    PMA / PMN Number
    K800207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A PERIPROSTHETIC FRACTURE, STEM SUBSIDENCE, AND DISLOCATION INVOLVING A UHR BIPOLAR 28X53MM WAS REPORTED. THE STEM 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. WHILE THE STEM SUBSIDENCE WAS ABLE TO BE CONFIRMED, THE ROOT CAUSE OF THE PERIPROSTHETIC FRACTURE, STEM SUBSIDENCE, AND DISLOCATION COULD NOT BE DETERMINED BECAUSE OF A LACK OF INFORMATION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE 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. NOT RETURNED TO THE MANUFACTURER.

    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. P. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79751 UHR BIPOLAR 28X53MM IMPLANT KWL STRYKER ORTHOPAEDICS-MAHWAH MLHLY0

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention