BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPRES NECK PRESERVING STEM

    MDR report key: 20567799 · Received October 30, 2024

    Report

    Report Number
    3005180920-2024-00874
    Event Type
    Injury
    Date Received
    October 30, 2024
    Date of Event
    September 30, 2024
    Report Date
    October 30, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630345713384
    PMA / PMN Number
    K210263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 7 OCTOBER 2024. LOT: 2213834: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-DEC-2022. EXPIRATION DATE: 2027-NOV-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS DEPARTMENT A FEW MONTHS AFTER THE IMPLANTATION OF A PRIMARY TOTAL HIP ARTHROPLASTY (THA), THE PATIENT EXPERIENCED PAIN ASSOCIATED WITH STEM SUBSIDENCE. SUBSEQUENTLY, THE PATIENT REPORTED A LEG LENGTH DISCREPANCY, LEADING TO FUNCTIONAL DIFFICULTIES AND ULTIMATELY DECIDING TO UNDERGO REVISION SURGERY. DURING THE REVISION, PERFORMED FIVE MONTHS AFTER THE PRIMARY PROCEDURE, THE SURGEON FOUND THE STEM STABLE AND LEFT IT IN PLACE, ONLY REPLACING THE FEMORAL HEAD TO RESTORE THE PROPER LEG LENGTH. AVAILABLE X-RAY AND CT IMAGES SHOW LEG SHORTENING, WITH THE LESSER TROCHANTER RESULTING HIGHER THAN THE CONTRALATERAL SIDE, BUT NO RADIOLUCENCIES OR OTHER SIGNS OF LOOSENING ARE VISIBLE. THE CAUSE OF THE SUBSIDENCE REMAINS UNCLEAR. WHILE FACTORS SUCH AS BONE QUALITY OR POTENTIAL INITIAL UNDERSIZING OF THE IMPLANT MAY HAVE CONTRIBUTED TO THE ISSUE, WE DO NOT HAVE SUFFICIENT INFORMATION TO DRAW DEFINITIVE CONCLUSIONS. ALTHOUGH NO ROOT DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED, THE QUALITY OF THE PATIENT'S BONE AND THE SIZE OF THE CHOSEN IMPLANT MAY HAVE INFLUENCED THE REPORTED PROBLEM. THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    AS A RESULT OF THE PAIN REPORTED BY THE PATIENT, AN EXAMINATION WAS MADE, WHICH SHOWED A MAJOR SINKING OF THE STEM, RESULTING IN JOINT LIMITATION AND LAMENESS. THE PATIENT REQUESTED SURGERY. FIVE MONTHS AFTER THE PRIMARY, THE PATIENT UNDERWENT SURGERY BUT, AS THE STEM WAS WELL FIXED, THE SURGEON DID NOT REMOVE THE STEM (ALSO CONSIDERING THE PATIENT'S AGE, 81), AND CLEANED OUT OSSIFICATIONS, AND REPLACED THE HEAD TO REESTABLISH THE CORRECT GEOMETRY OF THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725332 MPRES NECK PRESERVING STEM HIP STEM LZO MEDACTA INTERNATIONAL SA 01.37.006 2213834 07630345713384

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention