BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR 01.25.012 COCR BALL HEAD 12/14 Ø 28 SIZE M 0

    MDR report key: 16741312 · Received April 14, 2023

    Report

    Report Number
    3005180920-2023-00268
    Event Type
    Injury
    Date Received
    April 14, 2023
    Date of Event
    March 15, 2023
    Report Date
    April 14, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805110
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13-APR-2023: LOT 2109389: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-OCT-2021. EXPIRATION DATE: 2026-10-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: LINER: VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER Ø 52/28 (K092265) LOT 2116153: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JAN-2022. EXPIRATION DATE: 2026-12-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 159 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. STEM: M-VIZION 01.22.009 PROXIMAL BODY Ø20MM L 60MM LAT (K170690) LOT 186407: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-DEC-2019. EXPIRATION DATE: 2024-11-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 11 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. STEM: M-VIZION 01.22.106 DISTAL STEM Ø17MM L 140MM STRAIGHT (K170690) LOT 2006791: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-OCT-2020. EXPIRATION DATE: 2025-10-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 14 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CUP: MPACT 01.32.152MB DOUBLE MOBILITY ACETABULAR SHELL Ø52 (K143453) LOT 2105720: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-OCT-2021. EXPIRATION DATE: 2026-10-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED SUCCESSFULLY THE STEM, HEAD, AND LINER. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO DEVELOPING A HEMATOMA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A NEW MEDACTA STEM AND HEAD AND REVISED THE MEDACTA CUP AND LINER WITH A COMPETITOR CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144842 BALL HEADS: COCR 01.25.012 COCR BALL HEAD 12/14 Ø 28 SIZE M 0 HIP BALL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.012 2109389 07630030805110

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention