This follow-up report is being submitted to relay corrected and additional information.Additional: h2, h6.Event description: the patient had an initial left tha on (b)(6) 2020.Subsequently, the patient experienced post-operative acute blood loss anemia and hypotension requiring medical intervention and prolonged hospitalization.Resolved (b)(6) 2020.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Mymobility clinical study report: patient data: id (b)(6), female, born (b)(6) 1951, 162 cm, 74 kg, bmi 28.2, significant past medical history consisting of oa, dizziness and ha.Findings: pre-op health score 70, moderate pain, no intra-operative complications identified, acute blood loss anemia and hypotension requiring medical intervention (possible transfusion, fluid replacement therapy, or both) prolonging hospitalization.Product evaluation: products remain implanted.Review of product documentation- device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: the patient had an initial left tha on (b)(6) 2020.Subsequently, the patient experienced post-operative acute blood loss anemia and hypotension requiring medical intervention and prolonged hospitalization.Resolved (b)(6) 2020.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.Anemia can be associated with different medical conditions or can be directly related to blood loss during a trauma, surgical procedure or surgical complication.Anemia depending on the cause can be monitored and treated minimally or if hemoglobin is significantly low, it could be indicated that medical intervention is necessary to treat, i.E.Administering blood or other medical interventions.As postoperative developement of anemia develops with no other identified cause, this signifies a postoperative procedure-related complication.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
|