SMITH & NEPHEW, INC. UNKN REDAPT ACET IMPL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 03/01/2023 |
Event Type
Injury
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Event Description
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It was reported that on literature review "total hip arthroplasty with cemented dual mobility cup into a fully porous multihole cup with variable angle locking screws for acetabular fractures in the frail elderly", 1 (one) patient suffered from deep vein thrombosis after having a primary total hip arthroplasty surgery with cemented dual mobility cup (polarcup) into a fully porous multihole cup (redapt) to treat a displaced acetabular fracture.The patient was treated with lmwh (low-molecular-weight heparin) for three months.The outcome of the patient in unknown.No further information is available.
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Manufacturer Narrative
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Van den broek m, govaers k.Total hip arthroplasty with cemented dual mobility cup into a fully porous multihole cup with variable angle locking screws for acetabular fractures in the frail elderly.Hip pelvis.2023 mar;35(1):54-61.Https://doi.Org/10.5371/hp.2023.35.1.54.H10: internal complaint reference: (b)(4).H3, h6.This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
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