All product features corresponded with the valid specifications of the waldemar link (b)(4) at the time, when the item was produced.For the visual inspection there was one picture of the self-locking and the test screw available.No deviations are visible.The affected tibial component, pe plateau or pictures of the implant were not available for the investigation.Because of that we cannot comprehend the root cause of this failure.It is assumed that something blocked the hole of the pe-plateau during surgery.The implant was checked and assembled with the pe-plateau and trial screw prior shipping, no deviation were noticed.The waldemar link (b)(4) is aiming for the highest product quality and trying to keep the failure rate as low as possible by means of the customer feedback.Permanent employee trainings and market surveillance are performed.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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Self-locking screw could not be placed on the tibial plate component.When trying to place it through the polyethylene insert (uhmwpe), this self-locking screw does not pass, does not screw and does not fix the uhmwpe on the tibial plate.Having to place the trial screw.As a result, the trial screw comes out and the polyethylene insert loses its fixation.
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