Model Number N/A |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 01/12/2018 |
Event Type
Injury
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Manufacturer Narrative
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Patient returned to a health care facility after having insufficient pain relief after and initial scp procedure.During evaluation, the health care facility noticed a foreign body/mass in the knee joint that had migrated distally in the tibia.The foreign body was removed and sent to a lab for further analysis.An additional report will be submitted once new information is available.
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Event Description
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Foreign body located beneath tissue on top of the tibia plateau.
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Manufacturer Narrative
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The product was requested, but not returned.The foreign body was sent to a lab for further analysis by the hospital; however, the hospital was unwilling to disclose the lab results or the x-ray images from the case.The regional director stated it appeared as though the material in the original surgery might have extravasated through an existing fracture or defect in the bone.
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Event Description
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Foreign body located beneath tissue on top of the tibia plateau.
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Search Alerts/Recalls
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