BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT MAX 127 HIP STEM #7

    MDR report key: 3023860 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01111
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K051738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING A PERIPROSTHETIC FRACTURE INVOLVING A SECUR-FIT MAX 127 HIP STEM #7 WAS REPORTED. THE EVENT WAS CONFIRMED. A REVIEW OF THE PROVIDED OPERATIVE REPORTS, IMPLANT SHEETS, AND X-RAYS BY A CLINICAL CONSULTANT INDICATED: ¿THE EARLY SUBSIDENCE DUE TO A PERIPROSTHETIC FEMORAL FRACTURE WAS LIKELY DUE TO AN UNRECOGNIZED INTRA-OPERATIVE FEMORAL FRACTURE DURING EITHER FEMORAL PREPARATION OR PROSTHETIC IMPACTION. THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS WERE RESPONSIBLE FOR THIS CLINICAL SITUATION.¿ A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINISHED GOODS WITH NO REPORTED DISCREPANCIES. A COMPLAINT HISTORY REVIEW CONFIRMED NO SIMILAR EVENTS FOR THE REPORTED LOT. THE INVESTIGATION CONCLUDED THAT THE EARLY SUBSIDENCE DUE TO A PERIPROSTHETIC FRACTURE WAS LIKELY DUE TO AN UNRECOGNIZED INTRA-OPERATIVE FEMORAL FRACTURE DURING EITHER FEMORAL PREPARATION OR PROSTHETIC IMPACTION. THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS WERE RESPONSIBLE FOR THIS CLINICAL SITUATION.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT HAS PERI PROSTHETIC FRACTURE 3 DAYS AFTER INITIAL SURGERY.

    Description of Event or Problem · 1

    PATIENT HAS PERI PROSTHETIC FRACTURE 3 DAYS AFTER INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127058 SECUR-FIT MAX 127 HIP STEM #7 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH MLNKH9

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention