BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT MAX 132 HIP STEM #8

    MDR report key: 2931377 · Received January 28, 2013

    Report

    Report Number
    0002249697-2013-00370
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    November 21, 2011
    Report Date
    January 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K051738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVENT REGARDING REVISION OF A SECUR-FIT STEM DUE TO PAIN AND POTENTIAL SUBSIDENCE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE REVISION OPERATIVE REPORT NOTES "RADIOGRAPHS DEMONSTRATED HIS FEMORAL STEM DRIFTING INTO VARUS AND WORSENING SINCE IT WAS IMPLANTED." HOWEVER THE STEM IS DESCRIBED AS "QUITE WELL FIXED AND SOLID" WHEN IT WAS ADDRESSED DURING THE REVISION. REVIEW OF THE MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED, "THE INDICATION FOR THE REVISION SURGERY IS NOT CLEAR AND THE SOURCE OF THE PAIN IS NOT DEMONSTRATED TO BE RELATED TO EITHER THE PRIMARY OR REVISION COMPONENTS. THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS WERE RESPONSIBLE FOR THIS CLINICAL SITUATION. DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW FOUND NO OTHER EVENTS FOR THE SUBJECT LOT CODE. THE SUBJECT STEM WAS REVISED FOR INCREASING PAIN AND POTENTIAL SUBSIDENCE. THE REVISION OPERATIVE REPORT DESCRIBED THE STEM AS WELL FIXED AND SOLID AT THE TIME OF REVISION SURGERY. REVIEW OF THE MEDICAL RECORDS BY A CONSULTING CLINICIAN FOUND NO INDICATION THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS WERE RESPONSIBLE FOR THIS CLINICAL SITUATION. THE ROOT CAUSE IS DETERMINED TO BE PATIENT FACTORS.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN LEFT STRYKER HIP. 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 DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: PATIENT WAS EXPERIENCING A LOT OF PAIN SINCE HAVING ORIGINAL SURGERY. PATIENT STATES THAT THE PAIN WAS IN HIS HIP JOINT. PATIENT ALSO STATES THAT THE IMPLANT DID NOT KNIT WELL. PATIENT HAD REVISION SURGERY (B)(6) 2011. PATIENT STATES THAT HE WAS VERY ACTIVE BEFORE SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: PATIENT WAS EXPERIENCING A LOT OF PAIN SINCE HAVING ORIGINAL SURGERY. PATIENT STATES THAT THE PAIN WAS IN HIS HIP JOINT. PATIENT ALSO STATES THAT THE IMPLANT DID NOT KNIT WELL. PATIENT HAD REVISION SURGERY (B)(6) 2011. PATIENT STATES THAT HE WAS VERY ACTIVE BEFORE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37578 SECUR-FIT MAX 132 HIP STEM #8 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH MHTD8W

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention