BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28

    MDR report key: 9675276 · Received February 6, 2020

    Report

    Report Number
    3005180920-2020-00026
    Event Type
    Injury
    Date Received
    February 6, 2020
    Date of Event
    January 7, 2020
    Report Date
    February 6, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809323
    PMA / PMN Number
    K131518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 JANUARY 2020. LOT 19C0002: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-JAN-2019. EXPIRATION DATE: 2024-01-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: HIP DISLOCATION 6 MONTHS AFTER PRIMARY IMPLANTATION. HIP DISLOCATION MAY BE DUE TO COMPONENT POSITIONING OR INSUFFICIENT SOFT TISSUE TENSIONING; IT CAN HARDLY BE CAUSED BY STANDARD DEVICES. OTHER DEVICE INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 13 JANUARY 2020. LINER: CC E CC LIGHT 01.26.2837 HCT FLAT PE HC LINER Ø 28 / B (K122911) LOT. 185869 LOT 185869: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2018. EXPIRATION DATE: 2023-08-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON INITIALLY PLANNED TO REVISE THE CUP, BUT AFTER OPENING THE PATIENT DECIDED TO ONLY REVISE THE SLEEVE AND HEAD DUE TO THE PATIENT HAVING POOR BONE QUALITY AND AGE. THE SURGERY WAS COMPLETED SUCCESSFULLY ALMOST 5 MONTHS AFTER PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139775 BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28 HIP IMPLANT, CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.230H 19C0002 07630030809323

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention