It was reported that hip revision surgery was performed.During the revision, a synergy stem and bhr head were removed.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.Without definitive lot numbers a complete complaint history, manufacturing record, specific product labelling and ifus review cannot be performed for the devices involved.Without the details of the devices, medical details of the reported issue, failure modes and reason for revision involved in this complaint, a specific risk management review for the devices cannot be performed.If this information becomes available at a later time, the tasks will be reopened and completed.No medical records or evidence have been received on this complaint.The reported event cannot be assessed and a thorough medical assessment cannot be performed.If notification is received that additional medical documentation has been provided, this complaint will be re-evaluated and a thorough medical assessment rendered.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.
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