(b)(4).No device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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"in the article ¿the results of arthroplasty in osteoarthritis of the shoulder¿ by j.F.Haines; i.A.Trail; d.Nuttall; a.Birch; and a.Barrow; published in the journal of bone and joint surgery (br), vol.88-b, no.4, april 2006, was reviewed.The purpose of the study was to analyze 1124 shoulder arthroplasties (113 patients) carried out for osteoarthritis.The clinical results showed improvement in the constant score and the american shoulder and elbow surgeons score of 22 and 43, respectively.The arthroplasties were performed between 1992 and 2002 using the global shoulder replacement (depuy international, ltd, leeds, united kingdom).42 patients had humeral head replacement and 82 had tsa.The study reports significant improvement after operation in all parameters studied.The article states that the global shoulder replacement gives good results with significant functional improvement, which is subsequently maintained.It also reports that when the rotator cuff is intact, superior migration did not occur; glenoid erosion and a poor rotator cuff are related to poor results.Complications noted are: two patients experienced a hematoma which required surgical drainage.Three patients experienced infection.One patient experienced a nerve injury which recovered partially.Two patients had a fracture of the humeral shaft occur intraoperatively.One patient experienced a cerebrovascular accident within one month of surgery.Patients were also noted to experience pain, superior migration, glenoid erosion and glenoid loosening.
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