This user facility is outside of the united states.The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Event is being reported to fda on one medwatch since the limited information available indicates that a revision procedure occurred.Should additional information be received regarding the revision procedure, the complaint will be reassessed and, if warranted, further medwatch reports will be submitted.There are warnings in the package insert that this type of event can occur.Under possible adverse effects, number 8 states, "early or late postoperative, infection, and allergic reaction." product location unknown.
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