Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: tri ts femur sz2 left; cat# 5512-f-201; lot# jjom, tri ts baseplate size 1; cat# 5521-b-100; lot# ggoma, dura duration all poly pat xsm; cat# 6642-2-040; lot# 00515424, tri post augment sz2 10mm; cat# 5544-a-200; lot# gzvm, tri press-fit stem 14mm x 100mm; cat# 5565-s-014; lot# m7v35a, tri cemented stem 12mmx50mm; cat# 5560-s-112; lot# 0035629h, triathlon sym cone aug sz a; cat# 5549-a-110; lot# a608, it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
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