Model Number N/A |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/07/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a revision procedure due to unknown reasons.Attempts have been made to obtain additional information and at this time, no additional information is available.
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Manufacturer Narrative
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(b)(4).G2: foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 01072, 0001825034 - 2023 - 01074, 0001825034 - 2023 - 01073.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.
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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; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided medical records were 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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There is no update to the prior event description provided.
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Event Description
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It was reported that the patient underwent a right hip revision as patient's soft tissue was impinging.The navigation was used to add version to the cup.There is no additional information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Correction: initial medwatch was submitted with a notification date of may 2, 2023 in g3 and submitted on may 16, 2023; however, the correct notification date is march 7, 2023.
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Search Alerts/Recalls
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