Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Complaint, Ill-Defined (2331)
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Event Type
Injury
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Event Description
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It was reported a patient enrolled in a clinical study underwent a left partial knee arthroplasty on (b)(6) 2008.Subsequently, patient alleged experiencing a limp.Patient expired on (b)(6) 2012 due to unknown causes.
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Event Description
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It was reported a patient enrolled in a clinical study underwent a left partial knee arthroplasty on (b)(6), 2008.Subsequently, patient alleged experiencing a limp.Patient expired on (b)(6), 2012 due to respiratory failure.
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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.
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Manufacturer Narrative
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This tibial bearing is not 510(k) cleared for use with the cementless high flex partial knee system and does not require medical device reporting per 21 cfr part 803.Please disregard this manufacturer report number.
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Manufacturer Narrative
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The follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.
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Search Alerts/Recalls
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