The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that this complaint was reported from the literature review, ¿failure mechanisms and closed reduction of a constrained tripolar acetabular liner.¿ in the review, it was reported that a revision surgery was performed due dislocation.The head and liner were removed; however, the liner was a competitor device.After three requests, no relevant clinical information has been provided for inclusion in this medical investigation.In addition, the physician referenced in the abstract provided an analysis of all of the attached x-rays.Therefore, no further interpretation of the attached x-rays are required.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes of this event could include surgical technique or patient anatomy.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.
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