Evaluation summary: no product was returned for evaluation.
Also, no x-rays or operative notes were returned for review.
Patient health, medical history, activity level and conformance to the rehabilitation regimen can contribute to the success or failure of any implanted device - none of which are known in this case.
Based on the available information, a definitive root cause cannot be ascertained at this time.
No product was returned.
Review of the device history records did not find any deviations or anomalies.
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 investigation, the need for corrective action is not indicated.
Should additional substantive information be received, the complaint will be reopened.
Zimmer, inc considers the investigation closed.