BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED LAT STEM SIZE 3

    MDR report key: 9799442 · Received March 6, 2020

    Report

    Report Number
    3005180920-2020-00129
    Event Type
    Injury
    Date Received
    March 6, 2020
    Date of Event
    February 6, 2020
    Report Date
    March 6, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804199
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 FEBRUARY 2020. LOT 112383: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-AUG-2011. EXPIRATION DATE: 2016-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4) ITEM RE-STERILIZED AND RELEASED ON 24-JUN-2016. EXPIRATION DATE: 2021-06-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: PARTIAL HIP REVISION (STEM, HEAD AND LINER) PERFORMED 7 YEARS AND 8 MONTHS AFTER CEMENTLESS DOUBLE MOBILITY TOTAL HIP ARTHROPLASTY. IN THE RADIOGRAPHIC IMAGES PROVIDED, OSTEOLITIC REGIONS AROUND THE STEM ARE VISIBLE. OSTEOLYSIS MAY BE THE CONSEQUENCE OF POLYETHYLENE WEAR THAT IS COMMONLY SEEN AND DESCRIBED IN LITERATURE, HOWEVER WEAR WAS NOT MEASURED IN THIS CASE AND THEREFORE CORRELATION IS NOT ESTABLISHED. IT IS ALSO POSSIBLE THAT A BONE RESORPTION PROCESS HAS TAKEN PLACE (RADIOGRAPHIC HISTORY NOT AVAILABLE), BECAUSE IN THE PRE-REVISION IMAGES THE STEM LOOKS SLIGHTLY UNDERSIZED. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: FROM PRELIMINARY INVESTIGATION OF THE IMAGES PROVIDED IT IS NOT POSSIBLE TO DETERMINE IMPLANT'S FAILURE ROOT CAUSE OTHER IMPLANT INVOVLED IN THE EVENT: LINER: VERSAFITCUP DM 01.26.2848MHC DOUBLE MOBILITY HC LINER Ø 48/28 (K092265) LOT. 113816 BATCH REVIEW PERFORMED ON 06 MARCH 2020 LOT 113816: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-FEB-2012. EXPIRATION DATE: 2016-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN. THE SURGEON TOOK X-RAYS AND DETERMINED THE PATIENT HAD LOOSENING AND DISTAL POTTING. THE SURGEON REVISED THE LINER, HEAD, AND STEM 7 YEARS AND 8 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265302 STEM: AMISTEM H HA COATED LAT STEM SIZE 3 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.143 112383 07630030804199

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention