Model Number N/A |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Wound Dehiscence (1154)
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Event Date 05/03/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: medical product:oxf twin-peg cmntd fem sm pma, catalog #: 161468, lot #: 265770, medical product: oxf uni tib tray sz b rm pma, catalog #: 154721, lot #: 775280.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00479, 3002806535-2019-00480.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.
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Event Description
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It was reported that a patient underwent a right knee replacement procedure.Subsequently, the patient underwent surgery due to wound complications.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found in relation to this event.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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It was reported that a patient underwent a right knee replacement procedure.Subsequently, the patient underwent surgery due to wound complications.
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Search Alerts/Recalls
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