It was reported that there was an issue with as enduro femoral.Pre-operative diagnoses in 2018 included multidirectional instability of the left knee and pain following a left total knee arthroplasty (tka).The patient was initially implanted with enduro components on (b)(6) 2018.All components were cemented one-on-one with tobramycin and placement of stimulan pellets with 240mg of tobramycin follow by 100mg of vancomycin per mixture.Amniofix was placed for retardation of scarring over the posterior capsule and the sciatic nerve.There later was a failed left total knee and revision on (b)(6) 2020, and there had been increased pain prior to surgery.Black staining of tissues was noted.A revision surgery was necessary.The implants that were revised were the aesculap enduro components.A competitor's products were used instead, a porex component hinge.Additional information was requested.The adverse event is filed under xc (b)(4).Associated medwatches: 9610612-2020-00108 ((b)(4) nr880z), 9610612-2020-00120 ((b)(4) nr292z), 9610612-2020-00121 ((b)(4) nr400z), 9610612-2020-00122 ((b)(4) nb012z), 9610612-2020-00123 ((b)(4) nr192z).
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Associated medwatches: 9610612-2020-00108 (b)(4), (b)(4), 9610612-2020-00120(b)(4), 9610612-2020-00121 (b)(4), 9610612-2020-00122(b)(4), 9610612-2020-00123 (b)(4).Investigation no product at hand, therefore an investigation at the devices is not possible.Batch history review the device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from these batches.Conclusion and root cause based on the information available it is not possible to determine a definitive root cause for the failure at that time.Rationale on the basis of the current information and without a product for investigation, a clear conclusion/root cause for the implant loosening can not be drawn.Corrective action product safety case was created.
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