The following devices were also listed in this report: triathlon symmetric x3 patella; cat# 5550-g-278; lot# jvle.Triathlon ps fem comp #2r-cem; cat# 5515f202; lot# s4hkd.Tri cemented stem 12mmx50mm; cat# 5560-s-112; lot# n5n22d.Tri ts baseplate size 3; cat# 5521-b-300; lot# fsnp.Med howmedica bone plug 1pk; cat# 6215-5-011; lot# cpple05bh.Simplex p with tobramycin 1 pack; cat# 6197-9-001; lot# mfs042.Simplex p with tobramycin 1 pack; cat# 6197-9-001; lot# mfs042.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An event regarding alleged arthrofibrosis involving a triathlon insert was reported.The event was confirmed.Medical records received and evaluation: a review of the primary and revision operative reports, office notes and x-ray printouts by the consulting clinician indicated "there is no examination of the explanted components, no description of wear or loosening of the components, and no evidence, either growth or histologic, of a description of adverse reaction to the primary total knee components.The clinical situation is typical of a diagnosis of reflex sympathetic dystrophy and arthrofibrosis, which apparently was not resolved by extensive revision surgery.There is no evidence this was related to factors of faulty primary total knee component design, manufacturing or materials." device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the event was confirmed.However, the root cause could not be determined because the devices were not returned for evaluation and insufficient medical information was provided.A review of the primary and revision operative reports, office notes and x-ray printouts by the consulting clinician indicated "there is no examination of the explanted components, no description of wear or loosening of the components, and no evidence, either growth or histologic, of a description of adverse reaction to the primary total knee components.The clinical situation is typical of a diagnosis of reflex sympathetic dystrophy and arthrofibrosis, which apparently was not resolved by extensive revision surgery.There is no evidence this was related to factors of faulty primary total knee component design, manufacturing or materials." a trend analysis was conducted for the reported failure mode and concluded knee arthrofibrosis is most likely a result from other factors not necessarily related to the device in the healthcare facility setting.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
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It was reported by the patient's attorney through the filing of a legal claim that allegedly, the patient underwent a right total knee replacement on an unknown date.It is further alleged that the patient was then revised on (b)(6) 2013 due to impaired function of her knee.Update: "the clinical situation is typical of a diagnosis of reflex sympathetic dystrophy and arthrofibrosis, which apparently was not resolved by extensive revision surgery.".
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