At about 1 year after medacta primary surgery, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all components, performed a washout, and reimplanted permanent hardware.The surgery was completed successfully.Patient had competitor components prior to medacta revision system implantation.
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Batch review performed on 18-mar-2024.Lot 2238093: (b)(4) items manufactured and released on 29-nov-2022.Expiration date: 2027-11-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Other devices involved: gmk-revision 02.07.0683l revision fixed tibial tray cemented size 3 l (k123721) lot 2215011: (b)(4) items manufactured and released on 12-oct-2022.Expiration date: 2027-09-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Gmk-revision 02.07.2403l femur revision ps size 3 l (k102437) lot 2207826: (b)(4) items manufactured and released on 25-aug-2022.Expiration date: 2027-07-28.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.
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