Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.3, h.6, h.10 and h.11 based on the results of investigation.Reported event: dr.(b)(6) had a patient receive a stress fracture at the tibial pin site six months ago and is still recovering from it.Case type: tka.Additional information from mps: here is all the information i received yesterday regarding the stress fracture complaint: patient is 6 month post op.Has stress fracture at tibial pin site.Patient is still healing.Product evaluation and results: product inspection was not performed as product was not returned for inspection.Product history review: product history review was not conducted as lot number is not provided.Complaint history review: complaint history review was not conducted as lot number is not provided.Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.H3 other text : product was not available for evaluation.
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