WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY ADAPTIS TOTAL ANKLE SYSTEM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 33680005 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bone Fracture(s) (1870); Pain (1994); Osteolysis (2377); Swelling/ Edema (4577)
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Event Date 07/21/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device remains implanted in the patient.
If additional information becomes 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 experienced a spontaneous increase in swelling and pain which was exacerbated 2 days later.
The patient reports increased swelling is very apparent when showering.
The surgeon obtained an xray of the foot which showed a medial malleolar stress fracture.
Patient was placed in a fracture boot.
Rice treatment.
8 days later it was reported that the patient was worsening.
The patient notes increasing pain at the medial malleolus and fracture site, exacerbated by weight bearing.
X-rays taken which show an abundant periosteal reaction about the medial malleolus fracture and increased lucency at fracture line.
Total ankle prosthesis appears stable.
Treatment options were discussed.
Discussed observation with wbat in fracture boot vs nwb with crutches vs surgical treatment.
The patient underwent an orif medial malleolus six days later.
Adverse event is improving.
2 week follow-up of right medial malleolus stress fracture s/p orif medial malleolus.
Patient had a right ankle replacement with deformity correction.
Patient is doing well, making expected progress and pain is well-controlled.
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