Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Malunion of Bone (4529)
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Event Date 05/08/2014 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.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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It was reported patient was revised on unknown date due to pseudoarthrosis.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.Reported event was unable to be confirmed due to limited information received from the customer.Device history record 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.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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Event Description
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It was reported patient was revised approximately two months post implantation due to pseudoarthrosis.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.D10: 47248403050 62533159 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head.47248403050 62525781 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head.47248402750 62449958 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head.47248403050 62533159 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head.47248406050 62219029 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head.47248404550 62300685 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head.47248403550 62366754 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head.
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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/corrected updated: h2; h3; h6 reported event was confirmed by review of medical records received.Review of the available records identified the following: initial surgery for open fracture with massive preoperative lower leg hematoma.Revision for wound healing disorder.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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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