BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM C CEMENTED STD SIZE 2

    MDR report key: 9494690 · Received December 19, 2019

    Report

    Report Number
    3005180920-2019-01087
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    December 2, 2019
    Report Date
    December 19, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804274
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 DECEMBER 2019: LOT 176514: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-NOV-2017. EXPIRATION DATE: 2022-11-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED. BATCH REVIEWS PERFORMED ON 13 DECEMBER 2019: BALL HEADS: COCR 01.25.012 COCR BALL HEAD 12/14 28 SIZE M 0 (K072857) LOT 174666: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 8-NOV-2017. EXPIRATION DATE: 2022-10-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CUP: VERSAFITCUP 01.26.52MB ACETABULAR SHELL CC 52 (K083116) LOT 172681: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-NOV-2017. EXPIRATION DATE: 2022-11-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. LINER: VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER 52/28 (K092265) LOT 174323: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2017. EXPIRATION DATE: 2022-11-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT(0244-18 MR 2019-00142). CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: DELAYED INFECTION IN HYBRID THA, 2 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.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 1 YEAR AND 10 MONTHS AFTER THE PRIMARY DUE TO INFECTION AND IMPLANT MOBILIZATION (THE PATHOGEN IS UNKNOWN). THE SURGEON REMOVED THE CUP, BALL HEAD, LINER AND STEM AND INSERT A SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288209 STEM: AMISTEM C CEMENTED STD SIZE 2 CEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 176514 07630030804274

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention