BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S

    MDR report key: 17215233 · Received June 28, 2023

    Report

    Report Number
    3005180920-2023-00466
    Event Type
    Injury
    Date Received
    June 28, 2023
    Date of Event
    May 30, 2023
    Report Date
    June 28, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809194
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06-JUN-2023 LOT 2109343: 200 ITEMS MANUFACTURED AND RELEASED ON 27-OCT-2021. EXPIRATION DATE: 2026-10-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. OTHER DEVICE INVOLVED: LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT 2114162: 154 ITEMS MANUFACTURED AND RELEASED ON 26-OCT-2021. EXPIRATION DATE: 2026-10-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 150 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH TWO OTHER SIMILAR REPORTED CASES DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED SUCCESSFULLY THE HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702197 BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S HIP FEMORAL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.208 2109343 07630030809194

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention