It was reported that on literature review, "therapeutic effect of double-bundle anatomical medical patello-femoral ligament reconstruction under arthroscope in treatment of recurrent dislocation of patella in adolescents", a patient had limited knee flexion after surgery with an endobutton.The complication was treated with progressive knee joint functional exercises along with manipulation release.The joint's functions improved after treatment.No further information is available.
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The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.A complaint history review concluded this was an isolated event.Attempts to obtain medical documents were unsuccessful and thus a thorough medical investigation was not performed.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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