Model Number N/A |
Device Problem
Unintended Movement (3026)
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Patient Problems
Pain (1994); Unspecified Tissue Injury (4559)
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Event Date 03/13/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Source: uk.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.
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Event Description
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It was reported through a study that a patient had soft tissue irritation and underwent reoperation for proximal screws removal approximately 1 year post implantation.Attempts have been made and there is no further information at this time.
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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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(b)(6).Updated: b4, b5, g3, h1, h2, h10 correction: d1 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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Manufacturer Narrative
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(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.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.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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