Results of investigation: the study of vlad veringa et al [1] reports 5 patients were treated using smith and nephew rt-plus hinge prosthesis and 1 patient presented local hematoma which led to rehabilitation temporization and imposed rest, elastic bandages and cryotherapy.One of them remitted was evacuated.The complaint device, used in treatment, was not received for investigation, a visual inspection could not be performed.The part and the batch number of the device is not known.Therefore, the batch record review and a complaint history review could not be performed.The device labeling were reviewed, the ifu for the complaint device (lit.No.12.24, ed.07/10) stated haematoma, wound haematoma and delayed wound healing among possible side effects resulting from knee arthroplasty.The severity and the failure mode are covered through our risk management.For medical investigation, the x-rays and photos within the study were reviewed; however, no specific patient identifier was given.Smith and nephew has not received adequate patient-specific documentation to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.It is noted the patient pain reduced considerably, excellent improvement of joint mobility and life quality.Based on our investigations the failure mode cannot be confirmed and the root cause of the problem stays undetermined due to insufficient information.To date, no further actions will be taken.Smith and nephew will monitor the devices for further similar issues.[1]: veringa, vlad et al,; "constrained rotating hinge prostheses in severe haemophilic knee osteoarthritis"; materiale plastice, volume 55, no.4, 2018, pages 708-711, https://www.Revmaterialeplastice.Ro/pdf/veringa%204%2018.Pdf.
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