Model Number N/A |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Limited Mobility Of The Implanted Joint (2671)
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Event Date 07/06/2015 |
Event Type
Injury
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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: under possible adverse effects, number 6 states, "inadequate range of motion due to improper selection or positioning of components." this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2016-00903 / 00904).
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Event Description
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It was reported that patient underwent right total knee arthroplasty on (b)(6) 2014.Subsequently, patient was revised on (b)(6) 2015 due to stiffness.The bearings were removed and replaced.
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Manufacturer Narrative
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This follow-up report is being filed to relay corrected information.
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Event Description
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It was reported that patient underwent right total knee arthroplasty on (b)(6) 2014.Subsequently, patient was revised on (b)(6) 2015 due to stiffness.During the procedure, bearings were implanted and removed due to a sizing issue.Another set of bearings were used to complete the procedure.
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Search Alerts/Recalls
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