Model Number N/A |
Device Problems
Fluid/Blood Leak (1250); Metal Shedding Debris (1804); Naturally Worn (2988)
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Patient Problems
Edema (1820); Toxicity (2333)
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Event Date 04/01/2011 |
Event Type
Injury
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Event Description
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Legal counsel for patient reported that patient underwent a total hip arthroplasty on (b)(6) 2006.Patient's legal counsel further reports a revision procedure was performed on (b)(6) 2011 due to elevated metal ion levels and metal debris within the joint.Operative report notes the presence of fluid and wear on the neck of the femoral stem.The modular head was removed and replaced.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.
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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: "elevated metal ion levels have been reported with metal on metal articulating surfaces." this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2015-01583 & 01584).
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
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Event Description
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Legal counsel for patient reported that patient underwent a right total hip arthroplasty on (b)(6) 2006.Patient's legal counsel further reports a revision procedure was performed on (b)(6) 2011 due to elevated metal ion levels and metal debris within the joint.Operative report notes the presence of fluid and wear on the neck of the femoral stem.The modular head was removed and replaced.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.
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Search Alerts/Recalls
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