Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Synovitis (2094); Limited Mobility Of The Implanted Joint (2671)
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Event Date 08/30/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: item# 110018485; twist-off scr 2.0x12 ns; lot# unk.Report source: foreign: event occurred in (b)(6).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: 0001825034-2020-03249.Device evaluated by manufacturer? remains implanted.
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Event Description
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It was reported that the patient underwent an initial surgery with twist-off screws.Two years post surgery, patient started experiencing stiffness on the right side.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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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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Manufacturer Narrative
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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 confirmed by review of operative notes.Review of the available records identified foot swelling and limited range of motion following the initial procedure.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.Zimmerbiomet 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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