BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 36

    MDR report key: 17903327 · Received October 10, 2023

    Report

    Report Number
    3005180920-2023-00717
    Event Type
    Injury
    Date Received
    October 10, 2023
    Date of Event
    September 8, 2023
    Report Date
    October 10, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809347
    PMA / PMN Number
    K131518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023 LOT 2309213: 20 ITEMS MANUFACTURED AND RELEASED ON 10-MAY-2023. EXPIRATION DATE: 2028-04-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED: LINER: MPACT 01.32.3644HC10A FACE-CHANGING 10° PE HC LINER Ø36/E (K183582) LOT. 2108167: (B)(4)ITEMS MANUFACTURED AND RELEASED ON 09-SEPT-2021. EXPIRATION DATE: 2026-08-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 5 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN, THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335651 BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 36 FEMORAL HEAD LZO MEDACTA INTERNATIONAL SA 2309213 07630030809347

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention