Info was received via published literature.Eval summary: neither operative notes nor x-rays are available for review.Component fit and orientation per the surgical technique is unk.Attempts have been made to obtain additional info however no info has been received to date.In general, pt factors that may affect the performance of the components include: age, bone quality, height/weight, activity level, type of activity (low impact vs.High impact), and relevant medical history with the info provided, a definitive root cause cannot be stated.Review of the device history records was not possible as the product and/or lot numbers required for retrieval were unavailable.It is not suspected that the product failed to meet specifications.The investigation could not verify or identify any evidence of product contribution to the reported problem.Based on the eval info, the need for corrective action is not indicated.Should additional substantive info be received, the complaint will be reopened.Zimmer, inc.Considers the investigation closed.
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