Model Number N/A |
Device Problems
Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)
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Patient Problems
Joint Dislocation (2374); No Code Available (3191)
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Event Date 11/12/2014 |
Event Type
Injury
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Event Description
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It was reported patient underwent a right partial knee arthroplasty on (b)(6) 2014.Subsequently, the patient was revised on (b)(6) 2014 due to the tibial bearing popping out when the patient stepped out of a truck.The tibial bearing was removed and replaced.
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: ¿dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions.¿.
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Manufacturer Narrative
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This follow-up report is being filed to correct and relay additional information, which was unknown at the time of the initial medwatch.
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Search Alerts/Recalls
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