The associated complaint devices were not returned.The clinical/medical team concluded, the x-ray provided confirmed the complaint description of the angle of the cup but without comparisons its not known if this was a migration or the implant angle.Without the explant, the requested clinical information , or the reason for the revision, a root cause for the unspecified post operative condition cannot be concluded.The future impact to the patient beyond the revision cannot be concluded.No further clinical/medical assessment is warranted at this time.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.
|