Information was received via published literature.Please reference the attached literature, "implant survivorship and clinical outcomes of the bigliani-flatow shoulder prosthesis at a mean of five years: a post-marketing surveillance study from three centres".Initial reporter ¿ the article was written by a.J.Weusten, s.K.Khan, m.J.Lawson-smith, j.Mcbirnie, w.Siebert and a.Rangan involving the hospitals the james cook university hospital, united kingdom, new royal infirmary of edinburgh, united kingdom and vitos orthopaedische klinik, germany.No device or photos were received; therefore the condition of the device is unknown.Device history records cannot be reviewed since the lot number is unknown.This device is used for treatment.Product history search cannot be completed since the lot number is unknown.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.A definite root cause cannot be determined with the information provided.
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