Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Event Description
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Information was received based on review of a journal article entitled, "minimally invasive oxford phase 3 unicompartmental knee replacement." this prospective study describes the outcome of the first 1000 phase 3 oxford medial unicompartmental knee replacements implanted using a minimally invasive surgical approach for the recommended indications by two surgeons and followed up independently.A patient was identified in the article that underwent partial knee arthroplasty on an unknown side on an unknown date.Patient follow-up results provided at 0.72 year post-implantation indicates patient underwent a revision surgery on an unknown date due to pain.There has been no further information provided and the patient outcome is unknown.
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Manufacturer Narrative
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The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.(b)(4).This information was originally reported on 1825034-2015-02246 which referenced a journal article written on a study that this patient took part in.
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Manufacturer Narrative
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This follow-up report is being filed to relay corrected information.
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Event Description
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Information was received based on review of a journal article entitled, "minimally invasive oxford phase 3 unicompartmental knee replacement." this prospective study describes the outcome of the first 1000 phase 3 oxford medial unicompartmental knee replacements implanted using a minimally invasive surgical approach for the recommended indications by two surgeons and followed up independently.A patient was identified in the article that underwent partial knee arthroplasty on an unknown side on an unknown date.Patient underwent a revision surgery.72 year post-implantation due to pain.During the procedure, patient was converted to a total knee system.There has been no further information provided and the patient outcome is unknown.
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Search Alerts/Recalls
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