(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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"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 13, (b)(6) male, two-stage revision, inlay exchange (dislocation), resection arthroplasty, hematoma.
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