Model Number N/A |
Device Problems
Break (1069); Detachment Of Device Component (1104); Malposition of Device (2616)
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Patient Problem
No Information (3190)
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Event Date 02/08/2016 |
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 warnings, it states, ¿improper selection, placement, positioning, alignment and/or fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.¿.
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Event Description
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It was reported that patient underwent left total hip arthroplasty on (b)(6) 2015.Subsequently, patient was revised on (b)(6) 2016 due to the liner disassociating from the cup.During the procedure, the surgeon noted that the liner might not have been fully engaged during initial implantation, and some of the tabs on the liner were broken off.The liner, the head, and the taper were removed and replaced by an active articulation liner and head.
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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.(b)(4).Examination of returned device found no evidence of product non-conformance.Review of the device confirmed the reported condition.Dimensional analysis could not be performed due to deformation of the device.A conclusive root cause for the event could not be determined.
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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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It was reported that patient underwent a hip revision procedure approximately two months post-implantation due to the liner disassociating from the cup.During the procedure, the surgeon noted that the liner might not have been fully engaged during initial implantation, and some of the tabs on the liner were broken off.The liner, the head, and the taper were removed and replaced by an active articulation liner and head.
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Search Alerts/Recalls
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