BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK TAPERLOC STEM

    MDR report key: 11782981 · Received May 6, 2021

    Report

    Report Number
    3002806535-2021-00162
    Event Type
    Injury
    Date Received
    May 6, 2021
    Report Date
    May 12, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCT HAS NOT BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION, THEREFORE, A THOROUGH INVESTIGATION HAS NOT BEEN POSSIBLE. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. THE ITEM NUMBER AND LOT NUMBER IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY AND THE COMPLAINT HISTORY WAS NOT PROVIDED. THE ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Description of Event or Problem · 0

    JOURNAL CASE REPORT: FIXATION OF THE SHORT GLOBAL TISSUE-SPARING HIP STEM. AUTHORS: M. J. NIEUWENHUIJSE, S. B. W. VEHMEIJER, N. M. C. MATHIJSEN, S. B. KEIZER ¿ HAAGLANDEN MEDICAL CENTER, THE HAGUE, THE NETHERLANDS. 2020. AIMS : SHORT, BONE-CONSERVING FEMORAL COMPONENTS ARE INCREASINGLY USED IN TOTAL HIP ARTHROPLASTY (THA). THEY ARE EXPECTED TO ALLOW TISSUE-CONSERVING IMPLANTATION AND TO RENDER FUTURE REVISION SURGERY MORE STRAIGHTFORWARD BUT THE LONG-TERM DATA ON SUCH COMPONENTS IS LIMITED. ONE SUCH COMPONENT IS THE GLOBAL TISSUE-SPARING (GTS) STEM. FOLLOWING THE MODEL FOR STEPWISE INTRODUCTION OF NEW ORTHOPAEDIC IMPLANTS, WE EVALUATED EARLY IMPLANT FIXATION AND CLINICAL OUTCOME OF THIS NOVEL SHORT-STEM THA AND COMPARED IT TO THAT OF A COMPONENT WITH ESTABLISHED GOOD LONG-TERM CLINICAL OUTCOME. METHODS : IN TOTAL, 50 CONSECUTIVE PATIENTS OVER 70 YEARS OLD WITH END-STAGE SYMPTOMATIC OSTEOARTHRITIS WERE RANDOMIZED TO RECEIVE THA WITH THE GTS STEM OR THE CONVENTIONAL TAPERLOC STEM USING THE ANTERIOR SUPINE INTERMUSCULAR APPROACH BY TWO EXPERIENCED HIP SURGEONS IN TWO HOSPITALS IN THE NETHERLANDS. PRIMARY OUTCOME WAS IMPLANT MIGRATION. PATIENTS WERE FOLLOWED USING ROUTINE CLINICAL EXAMINATION, PATIENT REPORTED OUTCOME USING HARRIS HIP SCORE (HHS), HIP DISABILITY AND OSTEOARTHRITIS OUTCOME SCORE (HOOS), EUROQOL FIVE-DIMENSION QUESTIONNAIRE (EQ5D), AND ROENTGEN STEREOPHOTOGRAMMETRIC ANALYSIS (RSA) AT THREE, SIX, 12, AND 24 MONTHS. THIS STUDY EVALUATED THE TWO-YEAR FOLLOW-UP RESULTS. RESULTS: IN ADDITION TO THE INITIAL MIGRATION PATTERN OF DISTAL MIGRATION (SUBSIDENCE, Y-TRANSLATION) AND RETROVERSION (Y-ROTATION) ALSO EXHIBITED BY THE TAPERLOC STEM, THE GTS STEM SHOWED AN INITIAL MIGRATION PATTERN OF VARIZATION (X-TRANSLATION COMBINED WITH Z-ROTATION) AND POSTERIOR TRANSLATION (Z-TRANSLATION). HOWEVER, ALL COMPONENTS STABILIZED ASIDE FROM ONE TAPERLOC STEM WHICH BECAME LOOSE SECONDARY TO MALPOSITION AND WAS LATER REVISED. CLINICAL OUTCOMES AND COMPLICATIONS WERE NOT STATISTICALLY SIGNIFICANTLY DIFFERENT WITH THE NUMBERS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CONCOMITANT PRODUCTS: THE PRODUCT HAS NOT BEEN RETURNED TO THE MANUFACTURER. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    JOURNAL CASE REPORT: FIXATION OF THE SHORT GLOBAL TISSUE-SPARING HIP STEM. AUTHORS: M. J. NIEUWENHUIJSE, S. B. W. VEHMEIJER, N. M. C. MATHIJSEN, S. B. KEIZER ¿ HAAGLANDEN MEDICAL CENTER, THE HAGUE, THE NETHERLANDS. THE JOURNAL REPORTED THAT IN ADDITION TO THE INITIAL MIGRATION PATTERN OF DISTAL MIGRATION (SUBSIDENCE, Y-TRANSLATION) AND RETROVERSION (Y-ROTATION) ALSO EXHIBITED BY THE TAPERLOC STEM, THE GTS STEM SHOWED AN INITIAL MIGRATION PATTERN OF VARIZATION (X-TRANSLATION COMBINED WITH Z-ROTATION) AND POSTERIOR TRANSLATION (Z-TRANSLATION). HOWEVER, ALL COMPONENTS STABILIZED ASIDE FROM ONE TAPERLOC STEM WHICH BECAME LOOSE SECONDARY TO MALPOSITION AND WAS LATER REVISED. CLINICAL OUTCOMES AND COMPLICATIONS WERE NOT STATISTICALLY SIGNIFICANTLY DIFFERENT WITH THE NUMBERS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683601 UNK TAPERLOC STEM HIP ARTHROPLASTY LPH BIOMET UK LTD. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R