BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED LAT STEM SIZE 2

    MDR report key: 8721215 · Received June 21, 2019

    Report

    Report Number
    3005180920-2019-00500
    Event Type
    Injury
    Date Received
    June 21, 2019
    Date of Event
    May 22, 2019
    Report Date
    June 21, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804182
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 JUNE 2019: LOT 100546: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 APRIL 2010. EXPIRATION DATE: 2015-05-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: STEM REVISION SURGERY PERFORMED ABOUT 8 YEARS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD MAN WITH A HISTORY OF DAIR. RADIOGRAPHIC IMAGES PROVIDED SHOW THE PRESENCE OF BONE ALTERATIONS INCLUDING HETEROTOPIC OSSIFICATION AND OSTEOLYTIC REGIONS AROUND THE STEM. RADIOGRAPHIC ALTERATION MAY BE SUGGESTIVE OF AN INFECTIVE PROCESS BUT ALSO SUBOPTIMAL POSITION OF THE CUP MAY HAVE CAUSED IMPINGEMENT. THE REASON OF THIS EVENT CANNOT BE DETERMINED ON THE BASIS OF INFORMATION RECEIVED. OTHER DEVICES WERE INVOLVED IN THE COMPLAINT. BATCH REVIEW PERFORMED ON 18 JUNE 2019: IMPLANTS FROM CERAMTEC 38.49.7175.455.00 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0. LOT. 681412 (NOT REGISTERED IN USA). MANUFACTURING PROCESS REVIEW PERFORMED BY CERAMTEC: THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFIL THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT OR NON-CONFORMITIES REGARDING STERILISATION. DUE TO A LACK OF CERAMIC PARTS FURTHER INVESTIGATIONS CANNOT BE DONE. CUP: VERSAFITCUP 01.26.52MB ACETABULAR SHELL Ø 52 LOT. 103044 (K083116). BATCH REVIEW PERFORMED ON 18 JUNE 2019: LOT 103044: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 NOVEMBER 2010. EXPIRATION DATE: 2015-09-30. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. LINER: VERSAFITCUP DM 01.26.2852M DOUBLE MOBILITY LINER Ø 52/28 LOT. 104182 (K083116). BATCH REVIEW PERFORMED ON 18 JUNE 2019: LOT: 104182: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 FEBRUARY 2011. EXPIRATION DATE: 2015-12-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 8 YEARS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A HIP INFECTION. THE SURGEON REVISED ALL THE DEVICE SUCCESSFULLY. THE INFECTION TYPE IS A MORAWIETZ (CLASS UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514400 STEM: AMISTEM H HA COATED LAT STEM SIZE 2 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 100546 07630030804182

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention