Model Number 25002111E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060)
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Event Date 03/11/2019 |
Event Type
Injury
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Manufacturer Narrative
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The root cause for the patient developing scar tissue was unable to be determined.The patient has undergone two revision surgeries due to scar tissue developing around the patella.The patient's medical history is unknown.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) year-old male patient underwent a revision surgery on (b)(6) 2019 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 and revised a distal femur component, a tibial poly spacer, a tibial hinge component, and a distal femur axial pin with identical implants.
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Manufacturer Narrative
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The root cause for the patient developing scar tissue was unable to be determined.The patient has undergone two revision surgeries due to scar tissue developing around the patella.The patient's medical history is unknown.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.The complaint was reported to onkos on (b)(6) 2020.
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Event Description
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A 39-year-old male patient underwent a revision surgery on (b)(6) 2019 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 and revised a distal femur component, a tibial poly spacer, a tibial hinge component, and a distal femur axial pin with identical implants.
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Search Alerts/Recalls
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