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Catalog Number UNKNOWN |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/13/2011 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00384, 0001822565-2024-00385, 0001822565-2024-00386, 0001822565-2024-00387, 0001822565-2024-00388, 0001822565-2024-00390, 0001822565-2024-00392, 0001822565-2024-00394 g2: foreign: (b)(6).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.H3 other text : product not returned.
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Event Description
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It was reported that the patient was revised due to unknown reasons.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
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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 the event is for a scheduled removal of a tibial & fibula plate and screws and is not a serious injury as no apparent harm occurred.This complaint will be considered not reportable.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 further reported that the patient experienced a tibia and fibula fracture and underwent a reduction and fixation.Subsequently, the patient underwent a scheduled procedure for removal of a tibial and fibula plate and screws approximately 18 months post initial procedure.The patient was not experiencing any adverse events.As indicated, the procedure was a standard of care removal and completed without complication.
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Search Alerts/Recalls
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