SMITH & NEPHEW, INC. UNKN GENESIS II TOTAL KNEE IMPL; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Fibrosis (3167)
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Event Date 11/06/2021 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).Doi: https://doi.Org/10.1016/j.Arth.2021.11.001.
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Event Description
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It was reported that, on literature review "survivorship comparisons of ultra congruent, cruciate-retaining and posterior-stabilized tibial inserts using a single knee system design: results from the australian orthopedic association national joint replacement registry" corresponding to data collected from 1999 to 2019, a total of 67523 patients underwent a primary tka surgery where genesis ii systems were implanted, 21635 had a cruciate-retaining insert, 33454 had a posterior stabilized insert and 12434 had a ultra-congruent insert.After the primary tka surgery, 45 patients who had cruciate-retaining insert, 77 patients who had posterior stabilized insert and 22 patients who had ultra-congruent insert, underwent a revision surgery due to arthrofibrosis.Current health status of the patients is unknown.Further information was not available.
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Manufacturer Narrative
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The devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.Based on the information provided, no further details will be available.Therefore, the impact to the patient beyond that which has already been reported cannot be confirmed nor concluded, since the current health status of the patients is unknown.Should any additional relevant medical information be provided, this case would be re-assessed.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include patient medical history and/or patient condition.The contribution of the devices to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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