The manufacturer became aware of a study from stanford university medical center, ca, usa.The title of this report is ¿simultaneous bilateral resection total shoulder arthroplasty with anatomic antibiotic cement spacer retention¿ which was published in october-2017 and is associated with the stryker reunion tsa.Within that publication, post-operative complications/ adverse events were reported.It was not possible to ascertain specific device catalog from the study, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 6 complaints were initiated retrospectively for different adverse events mentioned in the study.This product inquiry addresses pain and stiffness.1st event for left shoulder.The study reports, ¿the patient did well until 3 months before presentation, when he developed bilateral shoulder pain and stiffness.Two weeks later, he developed septic arthritis of the right wrist and underwent open irrigation and debridement, with synovial fluid cultures (b)(6).The patient was prescribed 6 weeks of intravenous cefazolin and noted that his shoulder symptoms resolved while he was taking antibiotics.¿.
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