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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Inflammation (1932); Pain (1994)
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Event Date 04/28/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient was revised due to infection, inflammation and pain.All products were removed and replaced.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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(b)(4).G2: foreign: poland.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01056, 0001825034-2023-01101, 0001825034-2023-01103, 0001825034-2023-01104, 0001825034-2023-01105, 0001825034-2023-01106, 0001825034-2023-01107, 0001825034-2023-01108.D11: unknown humeral bearing.Unknown baseplate.Unknown stem.Unknown humeral tray.Unknown screw qty x4.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, g1-2, g3, g7, h1, h2, h6, h10 proposed annex g code: mechanical (g04) - head no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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