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Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Impaired Healing (2378); Limited Mobility Of The Implanted Joint (2671)
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Event Type
Injury
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Event Description
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Patient had a radial head replacement surgery on (b)(6) 2014.The patient received a radial head prosthesis.This was an opened injury, other specifics of the injury are unknown.At 6 weeks postoperative, after an x-ray the patient was given permission to start using the arm.The second x-ray was done on (b)(6) 2014, that showed the 8 millimeter (mm) stem had cut out of the lateral radius.The patient stated that he had been 100 percent compliant with postoperative instructions.A revision will be done eventually.Timeframe of revision unknown.It was reported that the patient is experiencing a decreased range of motion and delayed healing.This report is for an unknown 8mm stem.This report is 2 of 3 for (b)(4).
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.This report is for one unknown 8 mm stem/unknown lot number.Without a lot number the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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