BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRYKER OMNIFLEX STEM

    MDR report key: 7114988 · Received December 13, 2017

    Report

    Report Number
    0002249697-2017-03589
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    September 22, 2017
    Report Date
    December 13, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A PERIPROSTHETIC FRACTURE INVOLVING AN UNKNOWN STEM WAS REPORTED. THE EVENT WAS CONFIRMED FOLLOWING A MEDICAL REVIEW BY CLINICAL CONSULTANT METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: A VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION WAS NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS AND X-RAYS BY A CLINICAL CONSULTANT INDICATED: "DISCUSSION: REVISION OF STRYKER FEMORAL HEAD AND OMNIFLEX STEM DUE TO PERIPROSTHETIC FRACTURE SOME 20-YEARS POST IMPLANTATION IN A MALE PATIENT OF (B)(6) WITH NEAR NORMAL BODY WEIGHT (BMI = 26). DURING SURGERY, SURGEON REPORTED OSTEOLYSIS AROUND THE ZIMMER HGP CUP SHELL. {....} - THE PERIPROSTHETIC FRACTURE WAS CONFIRMED ON BOTH X-RAY AND CT-SCAN, MADE BECAUSE PATIENT BECAME ANAEMIC AND A HEMATOMA OF THE HIP WITH ACTIVE BLEEDING WAS SUSPECTED BUT NOT CONFIRMED. NO TRAUMA WAS EXPLICITLY REPORTED AS CAUSE OF THE FRACTURE. AFTER A FEW DAYS REQUIRED FOR MEDICAL WORK-UP, REVISION SURGERY WAS PERFORMED WHERE THE FRACTURE AROUND THE STEM WAS CONFIRMED AND CONSEQUENTLY THE STEM EXPLANTED, OBVIOUSLY TOGETHER WITH THE MOUNTED FEMORAL HEAD. SIGNIFICANT OSTEOLYSIS WAS FOUND AROUND THE ZIMMER CUP LINER WHERE THIS HGP LINER WAS EXPLANTED. NO SURGICAL DETAILS WERE PROVIDED BUT THE PRESENCE OF SEVERE OSTEOLYSIS AROUND THE CUP SHELL ALLOWS TO CONCLUDE THAT POLY WEAR WAS QUITE LIKELY PRESENT {...,} PROCEDURE-RELATED FACTORS: THE OSTEOLYSIS AROUND THE ZIMMER HGP LINER DUE TO POLY WEAR DOES NOT RELATE TO A STRYKER PRODUCT. THE STRYKER OMNIFLEX STEM BECAME SECONDARILY INVOLVED BY THIS OSTEOLYTIC PROCESS ALSO ON THE FEMORAL SIDE CONTRIBUTING TO A FEMORAL PERIPROSTHETIC FRACTURE. PATIENT-RELATED FACTORS NONE. DEVICE-RELATED FACTORS: NONE. DIAGNOSIS: OSTEOLYSIS DUE TO POLYETHYLENE WEAR AROUND A ZIMMER HGP LINER INDUCED OSTEOLYSIS ALSO ON THE FEMORAL SIDE CONTRIBUTING TO PROGRESSIVE WEAKENING OF THE FEMORAL BONE UNTIL A SPONTANEOUS PERIPROSTHETIC FRACTURE OCCURRED AROUND THE STRYKER OMNIFLEX STEM REQUIRING REVISION. DEVICE HISTORY REVIEW COULD NOT BE PERFORMED AS THE DEVICE LOT IS UNKNOWN. COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS THE DEVICE LOT IS UNKNOWN. CONCLUSIONS: A REVIEW OF THE PROVIDED MEDICAL RECORDS AND X-RAYS BY A CLINICAL CONSULTANT CONCLUDED "OSTEOLYSIS DUE TO POLYETHYLENE WEAR AROUND A ZIMMER HGP LINER INDUCED OSTEOLYSIS ALSO ON THE FEMORAL SIDE CONTRIBUTING TO PROGRESSIVE WEAKENING OF THE FEMORAL BONE UNTIL A SPONTANEOUS PERIPROSTHETIC FRACTURE OCCURRED AROUND THE STRYKER OMNIFLEX STEM REQUIRING REVISION. IF ADDITIONAL INFORMATION AND/OR DEVICE BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON PERFORMED A REVISION OF PATIENT'S RIGHT HIP DUE TO PAIN AND HIP FRACTURE. DURING SURGERY, SURGEON REPORTED OSTEOLYSIS AROUND THE COMPETITOR SHELL. A COMPETITOR LINER AND STRYKER FEMORAL HEAD WERE EXPLANTED. REP REPORTED THAT THE OMNIFLEX STEM WAS WELL-FIXED AND WAS EXPLANTED. PATIENT WAS REVISED TO A STRYKER HEAD AND LINER .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893520 UNKNOWN STRYKER OMNIFLEX STEM HIP IMPLANT JDG STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R