Model Number N/A |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problems
Unspecified Infection (1930); Pain (1994); Swelling (2091)
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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 2.89 year post-implantation indicates patient underwent a revision surgery on an unknown date due to pain and swelling.Subsequently, an infection was suspected, and the patient underwent two-stage revision with antibiotics.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 and additional information, which was unknown at the time of the initial medwatch.The follow up article was written by h pandit in bone joint surg (br} 2015;97-b:1493-1500.Product location unknown.
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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 procedure 2.89 year post-implantation due to pain and swelling.Subsequently, an infection was suspected, and the patient underwent two-stage revision with antibiotics.There has been no further information provided and the patient outcome is unknown.
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Search Alerts/Recalls
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