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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hematoma (1884)
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Event Date 03/03/2014 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Additional concomitant medical products: unknown, unknown neck, unknown; unknown, biolox ceramic 36mm head, 27193379.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 mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 08531.Product location unknown.
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Event Description
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It was reported patient had an irrigation and debridement one month post-implantation due to a draining hematoma.The head, liner, and neck were exchanged.Attempts to obtain additional information have been made; however, no more is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Device history record (dhr) 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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Search Alerts/Recalls
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