Literature received entitled: "triple taper polished cemented stem in total hip arthroplasty".Update 27 aug 2019.¿triple taper polished cemented stem in total hip arthroplasty¿ was reviewed for mdr reportability.The study followed 455 patients who have undergone a primary total hip arthroplasty with implantation of a continuous triple-tapered c-stem.Depuy cmw cement was used during the primary operations.The article indicated no patients were revised for stem loosening and no stem was at risk for loosening.The acetabular cup and acetabular liner used during the primary operations is unknown.It is noted specific patient identifiers nor specific revision information was provided.The following adverse events were noted: only one patient was revised.The reason for revision was for a deep infection.The following postoperative complications were noted without revision: delayed wound healing, hematoma, trochanteric nonunion, dislocation, deep vein thrombosis (clinical diagnosis), pulmonary embolism (nonfatal), urinary retention/infection, and paralytic ileus.
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(b)(4).No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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