(b)(4).Visual examination of the pictures provided within the medical records found black tissue was removed from the knee.No product was returned or pictures provided of the devices; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review found knee pain 15 day¿s post op.X-ray review found implants were in good position.No dvt.Further medical records were not provided.This complaint was not confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Additional associated products and mdrs: 183108 van ps open intl fem-rt 65 65 lot# 196810, mdr: 0001825034-2021-03365.183640 vanguard ps tib brg 71/75 x 10 mm lot# 808960, mdr: 0001825034-2021-03367.
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It was reported that patient had right total knee arthroplasty.Subsequently, the patient underwent a knee reconstruction surgery approximately 8 years, 4 months post implantation and proceeded to participate in physical therapy post reconstruction.No implants have been removed.Attempts have been made and no further information is available.
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