(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.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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The literature article entitled ¿treatment strategies for infection after reverse shoulder arthroplasty¿ by reinhold ortmaier; herbert resch; wolfgang hitzl; michael mayer; ottokar studner; and mark tauber; published in eur j orthop surg tramatol online on june 8, 2013, was reviewed.The article¿s purpose was to report on a retrospective case series to describe specific treatment strategies for deep infection after reverse shoulder arthroplasty.During a 12-year period (between 1998-2010) 192 patients (192 shoulders ) were treated with either primary or revision rsa at the authors¿ institution.All procedures were performed by three experienced shoulder surgeons.The institution¿s shoulder database was searched for post-operative rsa infection.There were 21 shoulders in 21 patients treated for deep infection after rsa with a minimum follow-up time of 24 months.Of the 21 patients, one patient died from causes unrelated to the shoulder, which left 20 shoulders in 20 patients (95% follow-up rate).All 20 patients had interventions due to infection.Each patient is broken down with sex, age, treatment and complication (if any).Patient 18, (b)(6) male, two-stage revision, inlay exchange (dislocation), hematoma.
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