Catalog Number UNK KNEE FEMORAL HINGE PIN LPS |
Device Problems
Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Unspecified Infection (1930)
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Event Date 11/15/2022 |
Event Type
Injury
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Event Description
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Washout and poly exchange of patella and lps insert due to infection left side.Patient decided to walk without a zimmer frame and fell.Surgeon had received some results patient has a staph c infection and has been monitoring the patient, but when the patient fell yesterday afternoon he decided to take him into the theatre to check that everything was ok as well as do a washout.Specimens taken during the procedure.
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Manufacturer Narrative
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Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: 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.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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Search Alerts/Recalls
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