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Patient presented with pain.It was reported that exam reveals swelling through the ankle and pain with ankle motion.No wounds noted at the ankle or foot.Previous surgical incisions are fully mature.Palpable pulses noted.X ray reveals a dislocated polyethylene spacer.Patient was revised to fusion using t2 hindfoot nail.Patient's bone quality is good.Sales rep reported that non union, inflammation, infection and tissue damage were not reported.
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Evaluation revealed the received talar component, tibial component and the sliding core, uhmpwe, 9mm to be the subject products.No further associated products were reported.In the case presented a patient had been treated with star on (b)(6) 2012 due to a right ankle traumatic arthropathy.The patient presented to the hospital in (b)(6) 2016 as he was suffering from pain.The clinical examination revealed the following: ¿exam reveals swelling throughout the ankle and pain with ankle motion.No wounds noted at the ankle or foot.Previous surgical incisions are fully mature.Palpable pulses noted.X-ray reveals a dislocated polyethylene spacer.The talus is noted.The surgical plan today includes right total ankle explant, conversion to ankle fusion with possible iliac crest bone graft.¿ as the pain affected the activity, the patient requested a surgical intervention.The patient was revised in (b)(6) 2016, where the star implants were explanted and an ankle arthrodesis had been performed.The exact root cause for the repeated dislocation of the polyethylene sliding core could not be determined with the information given.Implant seating and alignment are influenced by multiple factors.Component subsidence may result from poor bone quality, osteolysis-related bone loss, or poor component positioning¿ patients with severe osteoporosis or avascular necrosis may not have strong enough bone to support the placement of a total ankle replacement.A number of factors affect risk of subsidence.Initial implant positioning may contribute to subsidence.Subsidence tends to occur in the anterior distal tibia, dorsiflexing the tibial component, or in the anterior talus or posterior talus.Anterior translation of the talar component or excessive dorsiflexion of the tibial component should be avoided to prevent overloading the bone in these at risk areas¿ sudden change in implant position in the setting of osteolysis signifies loss of supporting bone.Revision or explantation and fusion may be necessary.Implant dislocation/ subsidence was furthermore clinically assessed by a consultant hcp: subsidence caused by collapse of the tibial bone or the talar bone structures or loss of the ligament stability of the ankle joint is a rare event, but will require removal of the endoprosthesis and ankle fusion.The returned sliding core was found to be slightly worn.The poly component was found to be significantly deformed at the medial edge.The observed surface damage was consistent with the reported dislocation.The returned tibial- and talar component showed signs of use.A damage or defect could not be identified.Based on the above information a deficiency of the items in question was not verified.The exact root cause of the reported event could not be determined, but was rather considered to be patient related.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product.No non-conformity was identified.In case relevant clinical information should become available, we reserve the right to update the investigation and change the root cause.
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Patient presented with pain.It was reported that exam reveals swelling through the ankle and pain with ankle motion.No wounds noted at the ankle or foot.Previous surgical incisions are fully mature.Palpable pulses noted.X ray reveals a dislocated polyethylene spacer.Patient was revised to fusion using t2 hindfoot nail.Patient's bone quality is good.Sales rep reported that non union, inflammation, infection and tissue damage were not reported.
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