SMITH & NEPHEW, INC. JII UNI TIB BASE SZ 2 LM/RL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71935194 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 04/26/2016 |
Event Type
Injury
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Event Description
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It was reported that, after a left medial unicompartmental knee replacement had been performed on an unspecified date to address osteoarthritis symptoms, the patient experienced an acute insufficiency fracture under the left medial plateau after a painful physiotherapy session.A revision surgery was performed on (b)(6) 2016 to treat this adverse complication.During this procedure, all components were revised as the knee was converted to a tka.According to the data set provided, this event occurred 0.5 months following the index implantation.The outcome of this patient is unknown.No further information is available.
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Manufacturer Narrative
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Internal complaint reference: case: (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through the review of clinical evidence from post market clinical data collection activities 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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