The patient had a primary competitor hip surgery on an unknown date.On (b)(6) 2021, the patient came in for unknown reasons and had a partial revision to a medacta stem, head and liner that was matched to the internal diameter of the existing acetabular implant from the initial resurfacing surgery.On (b)(6) 2023, the patient came in due to the development of a pseudo tumor that formed in the pelvis, behind the acetabular implant.The surgeon revised the competitor cup and medacta stem, head and liner to all new medacta components.The surgery was completed successfully.Note: it has been reported that there were no issues with medacta implants, the surgeon needed to remove everything to gain exposure to the tumor.
|
Batch review performed on 31-jul-2023: lot 2003321: (b)(4) items manufactured and released on 20-jul-2020.Expiration date: 2025-07-07.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of the review.Additional devices involved: batch reviews performed on 31-jul-2023: lot 2009388: (b)(4) items manufactured and released on 26-jan-2021.Expiration date: 2026-01-11.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 the review.Stem: masterloc 01.39.007 cementless ti coated std stem size 7 ((b)(6)) lot 171329: (b)(4) items manufactured and released on 06-oct-2017.Expiration date: 2022-09-25.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of the review.
|