WRIGHT MEDICAL TECHNOLOGY INC INFINITY¿ TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 33630021 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Implant Pain (4561)
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Event Date 04/04/2017 |
Event Type
Injury
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Manufacturer Narrative
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The device is not available for evaluation as it still remains implanted in the patient at this time.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.Device remains implanted in patient.
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Event Description
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It was reported that the patient underwent a prophecy infinity ankle implant surgery.Five years later, the patient is experiencing pain in the joint and needing a revision.
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Event Description
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It was reported that the patient underwent a prophecy infinity ankle implant surgery.Five years later, the patient is experiencing pain in the joint and needing a revision.
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Manufacturer Narrative
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The complaint could be confirmed, since the returned image for evaluation matches the alleged failure.Medical profession reviewed the received information and noted: irregularities could be found that would indicate why the patient had to undergo a revision, as the tibial implant has subsided, and cyst formation is present.There are no indications of irregularities of the implant itself and there are no indications for other irregularities.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.Based on investigation, the root cause was attributed to a patient factors issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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