Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.No device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported that this was an unknown surgery with delta products performed on (b)(6) 2022.After surgery, infection occurred.On unknown date, a revision surgery was performed.The product used at the glenoid site and cup were extracted, zimmer biomet¿s cement beads were filled, and cta head was inserted.Tissue was arranged for culture.The revision surgery was completed successfully with no surgical delay.The surgeon confirmed that infection was not product related.No further information is available.
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