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Model Number N/A |
Device Problems
Migration or Expulsion of Device (1395); Inadequacy of Device Shape and/or Size (1583)
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Patient Problems
Pain (1994); Limited Mobility Of The Implanted Joint (2671)
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Event Type
Injury
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Manufacturer Narrative
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The user facility is outside of the united states.Current information is insufficient to permit a conclusion as to the cause of the event.The product identification necessary to review manufacturing history was not provided.The following could not be completed with the limited information provided in the article: date of event - ni, expiration date - ni, date implanted - ni, date explanted - ni, (b)(6).Manufacture date ¿ ni.
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Event Description
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Information was received based on a review of a journal article titled, "valgus subsidence of the tibial component in cementless oxford unicompartmental knee replacement," which aimed to examine the clinical and radiological findings of patients whose tibial component subsides into a valgus positions with an increased posterior slope before becoming well-fixed.The situation appears to be avoidable by minor modifications to the operative technique, and it appears that it can be treated conservatively in most patients.It has been reported in the journal article that a patient experienced pain and stiffness.A radiograph indicated subsidence and an undersized tibial component.The patient was subsequently revised to a total knee and during the procedure, a tibial fracture was noted.
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Search Alerts/Recalls
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