All product features corresponded with the valid specifications of the waldemar link (b)(4) at the time, when the item was produced.The rotational bushing and the tibial plateau show traces of usage.A 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 due to poor soft tissue and obese constitution.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).
|