BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 5

    MDR report key: 11436147 · Received March 8, 2021

    Report

    Report Number
    3005180920-2021-00175
    Event Type
    Injury
    Date Received
    March 8, 2021
    Date of Event
    January 21, 2021
    Report Date
    August 3, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804113
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AWARENESS DATE 5 FEB 2021. REVISION DATE (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 FEBRUARY 2021: LOT 112814: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2011. EXPIRATION DATE: 2016-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2011. ADDITIONAL DEVICE INVOLVED. BATCH REVIEW PERFORMED ON 18 FEBRUARY 2021: LINER: CC E CC LIGHT 01.26.3244HCT FLAT PE HC LINER Ø 32 / E (K103352) LOT 113808: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-DIC-2011. EXPIRATION DATE: 2016-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2011. VISUAL INSPECTION PERFORMED BY MEDACTA R&D HIP PROJECT MANAGER: ANALYZING THE RECEIVED PIECES, NO PARTICULAR SIGNS WERE NOTICE ON THE STEM, THE HA COATING IS ABSORBED AS EXPECTED. ONLY ON A LIMITED PROXIMAL SURFACE THERE ARE SIGNS OF OSSEOINTEGRATION. NO EVIDENT SIGNS OF OSSEOINTEGRATION ARE PRESENT A LONG THE STEM. THE LINER ON THE INTERNAL SURFACE IS SLIGHTLY YELLOWED, MOST PROBABLY DUE TO LIPID ABSORPTION, AND WITH ONE HOLE SCREWED DURING THE SURGICAL EXTRACTION FROM THE SHELL. WITH A VISIVE ANALYSIS, NO PARTICULAR DEFORMATIONS OR ABNORMAL WEAR IS NOTICED. THE HEAD DO NOT SHOW ANY PARTICULAR SIGN OF WEAR, DEFORMATION OR PRESENCE TO THIRD BODIES. A FURTHER DIMENSIONAL ANALYSIS WAS PERFORMED THROUGH A 3D MC MACHINE, ANALYZING THE DIMENSIONS RELATED TO THE INNER SPHERICAL SEAT OF THE LINER; THE INNER SPHERE IS LESS THAN 0.1MM OVERSIZED AND ITS CENTER SEAMS TO SUNK OF 0.07MM FROM ITS THEORETICAL POSITION. WE ARE NOT ABLE TO DISCRIMINATE THESE CHANGES BETWEEN NATURAL CREEP OF THE PE LINER AND NATURAL WEAR. ALSO FOR THE BALL HEAD, THE MEASUREMENTS REVEALED THAT NO TRIBOLOGICAL DIMENSIONS ARE OUT OF TOLERANCE. IN CONCLUSION, THE LINER DOES NOT APPEAR TO BE WORN OUT ABNORMALLY. WE CAN STATE THAT THE DETECTED DIMENSIONS ARE VERY LIKELY COMPATIBLE WITH THE NORMAL USE OF THE LINER AFTER 9 YEARS. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: 9 YEARS AFTER PRIMARY CEMENTLESS THA THE IMPLANTS ARE REMOVED FOR LOOSENING OF THE STEM. IN THE RADIOLOGICAL HISTORY SUPPLIED, A RATHER SIGNIFICANT CORTICAL THICKENING, ONLY ON THE MEDIAL SIDE, IS VISIBLE IN THE MOST RECENT IMAGES. THERE ARE NO REPORTS OF INTERVENED FRACTURES DURING THE COURSE OF THE MEDICAL HISTORY SINCE PRIMARY SURGERY. THE STEM SHOWS RADIOLUCENCY IN ZONE 1 AND REDUCTION IN CORTICAL BONE DENSITY IN ZONES 6 AND 7, WHICH MAY BE RELATED TO OSTEOLYTIC PROCESS OR TO STRESS SHIELDING, SUPPORTED BY THE SIGNIFICANT DISTAL LOCKING OF THE STEM. THE REPORT MENTIONS PE PARTICLES WITH NO DETERMINATION OF QUANTITY: THE JOINT HAVING BEEN IN PLACE FOR 9 YEARS, WE CONSIDER THE PRESENCE OF PE PARTICLES IN THE SURROUNDINGS ALTOGETHER NORMAL, THOUGH NO INFORMATION ON QUANTITY IS AVAILABLE. NO ABNORMAL SIGNS OF WEAR WERE FOUND ON THE PE INSERT AND NO ABNORMAL DAMAGE TO THE IMPLANTED DEVICES WAS FOUND. IN ABSENCE OF TRAUMATIC EVENTS, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE FOR THE MOBILIZATION, AND WE TEND TO THINK IT WAS DUE TO THE SIMULTANEOUS PRESENCE OF SEVERAL FACTORS: STRESS SHIELDING, INITIAL OSTEOLYTIC PROCESS, STEM POTTING. THE COMBINATION OF THESE FACTORS IS RATHER COMMON IN THE COURSE OF MANY PRIMARY TOTAL HIPS, AS DOCUMENTED IN SCIENTIFIC LITERATURE AND NATIONAL REGISTERS, AND WE DID NOT FIND O DATE ANY EVIDENCE OF A DEFECTIVE DEVICE CAUSING THE ADVERSE EVENT.

    Description of Event or Problem · 1

    AMISTEM-H DUE TO LOOSENING AND SUSPECTED LINER WEAR. CHANGE OF STEM, HEAD AND LINER 9 YEARS AND 1 MONTH AFTER PRIMARY. SECONDARY DIAGNOSIS: LUPUS ERYTHEMATODES (ED 2008 UNDER METHOTREXAT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337236 AMISTEM H HA COATED STD STEM SIZE 5 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.135 112814 07630030804113

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention