Catalog Number SEE H10 NARRATIVE |
Device Problems
Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Date 02/27/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: 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.
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Event Description
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It was reported that the patient underwent a revision procedure due to pain.It was further indicated that the instrumentation was related to the revision.
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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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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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 the patient underwent a revision procedure approximately 2.5 years post implantation due to pain.The pain was caused by soft tissue irritation due to slightly prominent distal locking screw.Attempts to obtain additional information have been made; however, no more is available at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Product id was received for the screws.It is unknown which screw is the subject of this complaint therefore both are listed below: ti-dble lead cort 5.0x70mm scr cat: 14-405070 lot: unknown.Ti-dble lead cort 5.0x80mm scr cat: 14-405080 lot: unknown 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 the patient underwent a revision procedure due to pain.The pain was caused by soft tissue irritation due to slightly prominent distal locking screw.Attempts to obtain additional information have been made; however, no more is available at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause could not be determined.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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Search Alerts/Recalls
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