BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: CC E CC LIGHT FLAT PE HC LINER Ø 36 / F

    MDR report key: 9568608 · Received January 9, 2020

    Report

    Report Number
    3005180920-2019-01128
    Event Type
    Injury
    Date Received
    January 9, 2020
    Date of Event
    December 13, 2019
    Report Date
    January 9, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807688
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: DELAYED INFECTION IN CEMENTLESS THA, 8 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.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 7 JANUARY 2020: LOT 179315: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-APR-2018. EXPIRATION DATE: 2023-03-26. 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. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 7 JANUARY 2020: BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 179000. LOT 179000: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3-MAY-2018. EXPIRATION DATE: 2023-04-22. 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. STEM: QUADRA-H 01.12.028 CEMENTLESS, HA COATED STD STEM SIZE 8 (K082792) LOT. 185959 LOT 185959: 32 ITEMS MANUFACTURED AND RELEASED ON 11-DIC-2018. EXPIRATION DATE: 2023-11-27. 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 CC TRIO 01.26.45.1160 ACETABULAR SHELL CC TRIO NO-HOLE Ø 60 (K122911) LOT. 121904A. LOT 121904A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 9-APR-2018. EXPIRATION DATE: 2023-03-25. 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.

    Description of Event or Problem · 1

    REVISION OF ALL HIP COMPONENTS, 8 MONTHS AFTER PRIMARY SURGERY, DUE TO STREPTOCOCCOSIS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32651 LINER: CC E CC LIGHT FLAT PE HC LINER Ø 36 / F FLAT PE HC LINER LZO MEDACTA INTERNATIONAL SA 179315 07630030807688

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention