ONKOS SURGICAL ELEOS; SEGMENTAL STEM, CANAL FILLING, 16MM X 120MM, STRAIGHT, SPLINED, FULL PLASMA
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Model Number 2500SP16E |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Scar Tissue (2060)
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Event Date 10/16/2020 |
Event Type
Injury
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Manufacturer Narrative
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The root cause for the failure was unable to be determined.The patient has undergone a previous revision surgery for the same issue.The patient's medical history is unknown, and it is unknown whether the patient sustained a trauma prior to the failure.Based on review of the device history records and sterilization batch release records, it was concluded that the failure was not associated with the manufacture or the sterilization of the implants or a nonconformance.
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Event Description
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A (b)(6) male patient underwent a revision surgery on (b)(6) 2020 performed by dr.(b)(6) due to scar tissue forming around the patient's patella which was causing pain, stiffness, and a loss of range of motion of the knee.The surgeon debrided the scar tissue but did not replace the implants as they were deemed to not be affected and there were no failures found intraoperatively.
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Search Alerts/Recalls
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