SMITH & NEPHEW, INC. LEGION CON ART INS 9MM SZ 3-4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POL/M/POL
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Model Number 71420523 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Loss of Range of Motion (2032); Scarring (2061); Fibrosis (3167)
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Event Date 09/01/2020 |
Event Type
Injury
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Event Description
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It was reported that, after a tka had been performed on (b)(6) 2016, the patient developed scar tissue due to arthrofibroisis.A revision surgery was performed to treat the adverse event: there was no indication of infection.The insert 9mm was removed to gain access to the back of knee, and was replaced with size 9 pshf poly.It was noted at completion that range of motion was greater than pre-operatively.The patient outcome is unknown.
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Manufacturer Narrative
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The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device 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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