Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Date 11/16/2022 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).Report source: foreign source: japan.Concomitant medical products ¿ medical products.Item# 01-7347, lot# ni; "1.5mm" system plate 1.5 2 hole long straight.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2022-00382.
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Event Description
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It is reported that the patient underwent a revision procedure of a screw and plate due to an allergic reaction.The patient had pooling of fluid under the skin that caused the screw to float.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information is available at this time.
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Search Alerts/Recalls
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