BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 16893758 · Received May 9, 2023

    Report

    Report Number
    3005180920-2023-00357
    Event Type
    Injury
    Date Received
    May 9, 2023
    Date of Event
    April 19, 2023
    Report Date
    May 9, 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 26 APRIL 2023. LOT 2217241: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-OCT-2022. EXPIRATION DATE: 2027-10-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED BATCH REVIEWS PERFORMED ON 26 APRIL 2023. LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721) LOT 2213328: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JULY-2022. EXPIRATION DATE: 2027-07-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CUP: MPACT 01.32.156DH ACETABULAR SHELL Ø56 TWO-HOLES (K132879) LOT 2115418: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JAN-2022. EXPIRATION DATE: 2026-12-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. STEM: AMISTEM P 01.18.404 AMISTEM-P STD STEM SIZE 4 () LOT 2113942: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JAN-2022. EXPIRATION DATE: 2027-01-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. NB: SHELL AND STEM HAVE BEEN IMPLANTED DURING THE PRIMARY SURGERY ON (B)(6) 2022.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2022. ON (B)(6)2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, EXPLANTED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639202 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.210 2217241 07630030809217

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention