Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/04/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent revision surgery due an unknown reason.Due diligence is in progress for this event; to date no further information has been provided.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: item name: unknown oxford femoral component, item name: unknown oxford bearing.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2022-00446 and 3002806535-2022-00448.
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Manufacturer Narrative
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(b)(4) the following sections were updated: b4; b5; d9; g3; g6; h2; h3; h6; h10 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Devices are used for treatment.Insufficient information provided.Unable to perform a compatibility check.Complaint history review cannot be performed without product identification.Medical records were not provided.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 available at the time of this report.
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Search Alerts/Recalls
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