Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification were not provided for the patient mentioned in the journal article.(b)(4).The article was written by culp, randall w.; bachoura, abdo; gelman, scott e.; and jacoby, sidney m.
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Information was received based on review of a journal article titled, " proximal row carpectomy combined with wrist hemiarthroplasty " which aimed to present early experience with proximal row carpectomy (prc) combined with distal radius hemiarthroplasty using the maestro wrist reconstructive system radial component, manufactured by legacy biomet from april 2009 to june 2010.A competitor product was used from september 2010 onwards.Seventeen patients were identified in the article that underwent proximal row carpectomy combined with distal radius hemiarthroplasty with a maestro radial component on an unknown date.Mean postoperative flexion, extension, and grip strength were all less than preoperative levels.It is reported that a (b)(6) male with a history of slac iii wrist underwent right wrist arthroplasty.At the 14 month followup, radiograph findings included osteolysis in the distal half of the radial prosthesis.Patient was asymptomatic and did not undergo further treatment.At the 15 month followup, patient reported pain.No further information is available.
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