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: triathlon ps fem component, cemented; cat# 5515-f-502; lot# tuiitubp, triathlon asymmetric x3 patella; cat # 5551-g-320; lot # 1nme, tri ts baseplate size 4; cat # 5521-b-400; lot # tzwrb, simplex p with tobramycin 1 pack; cat # 6197-9-001; lot # mjw074, simplex with tobramycin 1 pack; cat # 6197-9-001; lot # mjw074, no 4.Triathlon ts plus tibial insert x3 poly 16mm; cat # 5537-g-416; lot # m65dep.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.
|