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Model Number N/A |
Device Problems
Collapse (1099); Fracture (1260)
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Patient Problem
Unspecified Infection (1930)
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Event Date 05/07/2012 |
Event Type
Injury
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Event Description
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Legal counsel for patient reported patient underwent a revision procedure on (b)(6) 2014, but did not give a reason for revision.Further follow up revealed that the patient underwent an initial knee procedure on an unknown date in which competitor product was implanted.The patient was revised to a biomet orthopedic salvage system on (b)(6) 2010 for an unknown reason.A second revision procedure was performed on (b)(6) 2012 due to collapse of the tibial components.All components were removed and replaced.Subsequently, two revision procedures were performed on (b)(6) 2012 due to infection.The bushings, bearings, axles, lock pins and yokes were removed and replaced during both revision procedures and the wound was irrigated.During the revision procedure performed on (b)(6) 2014, fracture of the femoral tabs was noted.All components were 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: under possible adverse effects, number 2 states, "early or late postoperative, infection, and allergic reaction." review of sterilization certification confirms device was sterilized in accordance with iso 11137-2.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This report is number 12 of 13 mdrs filed for the same event (reference 1825034-2014-07215 / 07218 & 07236 / 07245).
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Search Alerts/Recalls
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