BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 7

    MDR report key: 9826673 · Received March 12, 2020

    Report

    Report Number
    3005180920-2020-00148
    Event Type
    Injury
    Date Received
    March 12, 2020
    Date of Event
    August 28, 2017
    Report Date
    March 11, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804137
    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 3 MARCH 2020: LOT 163102: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-AUG-2016. EXPIRATION DATE: 2021-08-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION: LATE INFECTION IN CEMENTLESS THA, 2.5 YEARS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. OTHER DEVICES INVOLVED IN THE EVENT: CUP: VERSAFITCUP CC TRIO 01.26.45.1152 ACETABULAR SHELL CC TRIO NO-HOLE Ø 52 LOT. 171705 ((B)(4)). BATCH REVIEW PERFORMED ON 3 MARCH 2020: LOT 171705: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 9-JUNE-2017. EXPIRATION DATE: 2022-05-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. LINER: CC E CC LIGHT 01.26.3644HCT FLAT PE HC LINER Ø 36 / E LOT. 171722 ((B)(4)). BATCH REVIEW PERFORMED ON 3 MARCH 2020: LOT 171722: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUNE-2017. EXPIRATION DATE: 2022-06-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. IMPLANTS FROM CERAMTEC 38.49.7179.285.00 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 LOT. 7011140767. MANUFACTURING PROCESS REVIEW: REQUEST FOR DOCUMENT REVIEW SENT TO THE SUPPLIER CERAMTEC ON 03.03.2020. DUE TO THE LACK OF INFORMATION ABOUT THE LASER ENGRAVING, THE IDENTIFICATION OF THE BALL HEAD IS ONLY POSSIBLE BASED ON THE INFORMATION PROVIDED BY MEDACTA. THE BALL HEAD BELONGS TO THE SHIPPING ORDER (B)(4). PROTOCOL AND CERTIFICATE OF CONFORMANCE WERE REVIEWED. THE QUALITY DOCUMENTS (INCLUDING THE STERILIZATION CERTIFICATES) SHOW THAT THE VALUES OBTAINED ON THE BALL HEAD WERE ACCORDING TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFILL THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT OR NON-CONFORMITIES REGARDING STERILIZATION. DUE TO THE LACK OF CERAMIC PARTS FURTHER INVESTIGATIONS CANNOT BE DONE.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER 2 YEARS AND 6 MONTHS DUE TO STEM LOOSENING. INITIALLY, THE STEM WAS PLANNED TO BE REVISED, BUT DURING THE OPENING OF THE WOUND SOME PURULENCE WAS DISCOVERED AND BECAUSE OF THAT THE SURGEON DECIDED TO REMOVE THE ENTIRE PROSTHESIS AND IMPLANT A NEW HIP. THE INFECTION IS CONFIRMED, THE PATHOGEN IS PSEUDOMONAS AERUGINOSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290549 STEM: AMISTEM H HA COATED STD STEM SIZE 7 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.137 163102 07630030804137

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention