BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17773625 · Received September 19, 2023

    Report

    Report Number
    3005180920-2023-00737
    Event Type
    Injury
    Date Received
    September 19, 2023
    Date of Event
    August 28, 2023
    Report Date
    December 19, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809262
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 01 SEPTEMBER 2023: LOT 2203067: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAY-2022. EXPIRATION DATE: 2027-05-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL INVOLVED IMPLANTS BATCH REVIEW PERFORMED ON 01 SEPTEMBER 2023 ON CUP: MPACT 01.32.164DH ACETABULAR SHELL Ø64 TWO-HOLES (K132879) LOT. 2000236. LOT 2000236: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2020. EXPIRATION DATE: 2025-04-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 01 SEPTEMBER 2023 ON LINER: MPACT 01.32.4052HCT FLAT PE HC LINER Ø40/G (K122641) LOT. 2111817. LOT 2111817: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2021. EXPIRATION DATE: 2026-09-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 01 SEPTEMBER 2023 ON STEM: SMS SOLID 01.36.053 SMS SOLID STEM STD SIZE 13 (K181693) LOT. 2100581. LOT 2100581: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAY-2021. EXPIRATION DATE: 2026-04-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    ON 29 NOVEMBER 2023 AFTER ADDITIONAL CHECKS WITH THE BRANCH WE FOUND THAT THE PATIENT WAS ALREADY INVOLVED IN OTHER SURGERIES REPORTED IN OTHER COMPLAINT. SAME PATIENT OF MDR 2022-00637, 2022-00696, 2023-00238. WE MODIFIED THE PATIENT GENDER (MALE), THE DATE OF THE SURGERY ((B)(6) 2023) AND THE EVENT DESCRIPTION.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 YEAR FROM THE PRIMARY THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED NEW IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 5 MONTHS AFTER A PRECEDENT SURGERY FOR INFECTION THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED NEW IMPLANTS.THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447121 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE XL HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 2203067 07630030809262

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention