BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M

    MDR report key: 14160015 · Received April 20, 2022

    Report

    Report Number
    3005180920-2022-00271
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    March 21, 2022
    Report Date
    April 20, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    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 24 MARCH 2022. LOT 2100270: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-APR-2021. EXPIRATION DATE: 2026-04-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL COMPONENTS INVOLVED: BATCH REVIEW PERFORMED ON 24 MARCH 2022. STEM: M-VIZION 01.22.105 DISTAL STEM Ø16MM L 140MM STRAIGHT (K170690) LOT 2010764: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JUN-2021. EXPIRATION DATE: 2026-06-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. STEM: M-VIZION 01.22.408 PROXIMAL BODY Ø20MM L 50MM LAT WITH HOLES (K201471) LOT 2010781: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-SEP-2021. EXPIRATION DATE: 2026-08-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CUP: MPACT 01.32.156MH ACETABULAR SHELL Ø56 MULTI-HOLE (K132879) LOT 1904343: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-AUG-2019. EXPIRATION DATE: 2024-08-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT. LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721) LOT 1904357: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUL-2019. EXPIRATION DATE: 2024-06-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT HAD PRIMARY HIP SURGERY ON (B)(6) 2020. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM, AND THE SURGEON REVISED THE STEM AND HEAD. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN THE REPORT THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 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
    2749575 BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.209 2100270 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention