It was reported that due to a metallosis the shoulder and the arm of the patient turned black.The surgery which led to the reported event was a shoulder prosthesis which was performed on the (b)(6) 2015.According to the customer arthrex devices were implanted during the initial surgery in 2015.Currently it is not known in which hospital the initial surgery took place.Therefore no further information about the detailed incident and the used arthrex part numbers are currently available.Update 12-oct-2020: initially the lot numbers which were affected were not provided however further information were now provided that the following parts were used during the initial surgery 2015: ar-9120-01, lot: 140113110, ar-9145-30, lot: 140123108, ar-9504s-04, lot: 2501212801, ar 9165-15, lot: 140103207, ar-9145-30, lot: 2501417704, ar-9502-36cpc, lot: 140120310, ar -9501-07cpc, lot: 2501215303, ar-9503s-03, lot: 140104307, ar-9555-15, lot:2501215101, ar-7213, lot: 12812, ar-7200, lot: 12795.However it could not be confirmed which device has led to the reported issue and if the devices are available for evaluation.
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