Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Scar Tissue (2060); Limited Mobility Of The Implanted Joint (2671)
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Event Date 04/03/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: item# 110018419; hdls cmpn scr 2.5x18 ns; lot# unk.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: 0001825034-2020-03149.Remains implanted.
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Event Description
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It was reported that patient underwent initial surgery.Approximately, after a year patient started experiencing stiffness with scar tissue on the left foot.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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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 investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.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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