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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 11 states, "wear and/or deformation of articulating surfaces." the following sections could not be completed with the limited information provided.Device code - unknown.Expiration date - unknown.Pma/510(k) number.Manufacture date ¿ unknown.Event is being reported to fda on one medwatch as 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 further medwatch reports will be submitted, if necessary.
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