It was reported that after a left knee extra-capsular repair and mpfl reconstruction with q-fix, the patient had left knee arthrofibrosis due to post-operative stiffness.The event was treated with surgery and the patient recovered.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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H10 h3, h6: the device reported, used in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established.No product identification information was provided, thus a manufacturing and device record review could not be conducted.Although requested, no x-ray images or information on the patient compliance with post-operative instructions were provided for review.Clinical/medical evaluation was completed and concluded that without the requested clinical information a thorough medical investigation cannot be rendered.The reported issue has been documented as resolved due to the surgical intervention.Should any additional clinical information be provided this complaint will be re-evaluated.Review of the product instructions for use found adequate warnings and precautions to prevent damage to the device during use.Risk management documents were reviewed finding no additional risks that require to be added to the reference document.A visual inspection and functional evaluation cannot be performed and customer´s complaint cannot be confirmed.Potential factors unrelated to the design or manufacture of the device that may lead to the failure reported include, but are not limited to: (1) potential complications accompanying such implant surgery.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.
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