BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4

    MDR report key: 17396721 · Received July 26, 2023

    Report

    Report Number
    3005180920-2023-00601
    Event Type
    Injury
    Date Received
    July 26, 2023
    Date of Event
    July 11, 2023
    Report Date
    July 26, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809217
    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 18 JULY 2023: LOT 2109348: (B)(4) MANUFACTURED AND RELEASED ON 04-NOV-2021. EXPIRATION DATE: 2026-OCT-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED BATCH REVIEWS PERFORMED ON 18 JULY 2023 LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT 2109539: (B)(4) MANUFACTURED AND RELEASED ON 06-SEP-2021. EXPIRATION DATE: 2026-AUG-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. STEM: SMS SOLID 01.36.066 SMS SOLID STEM LAT SIZE 6 (K181693) LOT 2009521: (B)(4) MANUFACTURED AND RELEASED ON 21-DEC-2020. EXPIRATION DATE: 2025-DEC-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 24 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CUP: MPACT 01.32.152DH ACETABULAR SHELL Ø52 TWO-HOLES (K132879) LOT 2104110: (B)(4)MANUFACTURED AND RELEASED ON 07-JUN-2021. EXPIRATION DATE: 2026-MAY-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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 YEAR AND 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630364 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 2109348 07630030809217

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention