BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE S

    MDR report key: 19018523 · Received April 2, 2024

    Report

    Report Number
    3005180920-2024-00179
    Event Type
    Injury
    Date Received
    April 2, 2024
    Date of Event
    March 6, 2024
    Report Date
    April 2, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809231
    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 13 MARCH 2024. LOT 2315558: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUL-2023. EXPIRATION DATE: 2028-JUN-14. 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 IMPLANT INVOLVED. BATCH REVIEW PERFORMED ON 13 MARCH 2024 ON LINER: MPACT 01.32.4048HCT FLAT PE HC LINER Ø40/F (K122641) LOT. 2314080 LOT 2314080: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-AUG-2023. EXPIRATION DATE: 2028-JUL-10. 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.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 MONTH AFTER THE PRIMARY 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
    1051528 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE S HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 2315558 07630030809231

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention