BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S

    MDR report key: 16021048 · Received December 21, 2022

    Report

    Report Number
    3005180920-2022-00961
    Event Type
    Injury
    Date Received
    December 21, 2022
    Date of Event
    December 5, 2022
    Report Date
    December 21, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809156
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2022. LOT 2204271: 100 ITEMS MANUFACTURED AND RELEASED ON 19-MAY-2022. EXPIRATION DATE: 2027-MAY-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 78 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON (B)(6) 2022. LINER: MPACT 01.32.3239HCT FLAT PE HC LINER Ø32/C (K1037219) LOT 2109534: 132 ITEMS MANUFACTURED AND RELEASED ON 10-SEP-2021. EXPIRATION DATE: 2026-AUG-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 118 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 CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 3 WEEKS AFTER THE SURGERY, 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
    2024347 BALL HEADS: MECTACER 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S HIP DELTA CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.204 2204271 07630030809156

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention