All product features corresponded with the valid specifications of the (b)(4) at the time, when the item was produced.All components of the modular knee prosthesis were available for the investigation.The rotational bushing and the tibial component show no visible deviations.The sliding surface of the femoral component has scratches and the extension buffer is damaged.The backside of the pe-plateau is intact whereas the sliding surface is damaged.A functional test of the components showed conspicuous movement within the rotational bushing.A damage pattern as in the present case is known from cases of damage after functional overload of the components.The implant standing time was 4 years and 6 month.No further patient information, surgery reports and preoperative x-rays images were available for investigation.According to the quality documentation review and the investigation results a product failure is not assumed.The report is delayed due to inconsistencies with regard to foreign event reporting to fda.After re-evaluation of the complaint we determined that it is reportable.We have addressed the inconsistency in reporting foreign events to fda through capa (b)(4).
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