Product not returned and could not be evaluated.Provided radiographs confirm the alleged malfunction.Review of the reported information suggests undersized implant selection and/or excessive loading as the root cause.No additional investigation needed.Labeling review: ".Potential adverse events and complications: as with any major surgical procedures, there are risks involved in orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss of fixation." ".Warnings, cautions and precautions: correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants.Metallic internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone.These devices are not designed to withstand the unsupported stress of full weight or load bearing alone.Care should be taken to insure that all components are ideally fixated prior to closure." ".Pre-operative warnings: care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".Post-operative warnings: damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications." device discarded at user facility.
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