All product features correspond with the valid specifications of the waldemar link (b)(4) at the time, when the item was produced.Unfortunately the complaint sample was not returned to us for further investigations.So an exact root cause for the failure cannot be determined.The adiposity of the patient (bmi (b)(6)), which is described as a relative contra indication in our product catalogue, surely facilitated the wear of the polyethylene.This event occurred outside of the u.S.And involves a product that was manufactured outside of the u.S.However, because the affected product is also marketed in the u.S., waldemar link (b)(4) is submitting this mdr to ensure full compliance with 21 cfr part 803.(b)(4).
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