BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: MASTERLOC CEMENTLESS TI COATED LAT SIZE 3

    MDR report key: 9383332 · Received November 27, 2019

    Report

    Report Number
    3005180920-2019-00994
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    October 31, 2019
    Report Date
    December 6, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030885631
    PMA / PMN Number
    K160289
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION: SIGNS OF BONE RESIDUAL ON THE STEM, SCRATCHES ON THE FEMORAL NECK DUE TO EXTRACTION, REMOVAL RESIDUALS ALSO ON LINER AND FEMORAL HEAD.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05 NOVEMBER 2019: LOT 180817: 15 ITEMS MANUFACTURED AND RELEASED ON 20-JUN-2018. EXPIRATION DATE: 2023-06-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 14 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 05 NOVEMBER 2019: VERSAFITCUP CC TRIO 01.26.45.0050 ACETABULAR SHELL CC TRIO Ø 50 (K103352) LOT 183942: 160 ITEMS MANUFACTURED AND RELEASED ON 13-SEPT-2018. EXPIRATION DATE: 2023-09-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 156 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER: SCREWS 01.26.65.30 CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 30 (K103352) LOT 175094: 110 ITEMS MANUFACTURED AND RELEASED ON 13-SEPT-2017. EXPIRATION DATE: 2022-08-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 102 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 (K112115) LOT 177708: 120 ITEMS MANUFACTURED AND RELEASED ON 05-MAR-2018. EXPIRATION DATE: 2023-02-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 112 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: DELAYED INFECTION IN CEMENTLESS THA, 9 MONTHS 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. VISUAL INSPECTION PERFORMED BY MEDACTA HIP R&D PROJECT MANAGER: SIGNS OF BONE RESIDUAL ON THE STEM, SCRATCHES ON THE FEMORAL NECK DUE TO EXTRACTION, REMOVAL RESIDUALS ALSO ON LINER AND FEMORAL HEAD.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A REVISION SURGERY 9 MONTHS AFTER PRIMARY FOR INFECTION (ACNES BACTERIUM). STEM, CERAMIC LINER, CERAMIC HEAD AND SCREW REVISED SUCCESSFULLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175227 STEM: MASTERLOC CEMENTLESS TI COATED LAT SIZE 3 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 180817 07630030885631

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention