WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY¿ TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number UNK_WWA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Loss of Range of Motion (2032); Implant Pain (4561)
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Event Date 11/01/2021 |
Event Type
Injury
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Event Description
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Patient had an infinity ankle replacement device implanted on his right side at the end of (b)(6) 2021.He had done rehab for 5 months with good results, but has developed pain in the interior portion of his ankle where it meets the tibia.The pain is now at a high degree at any activity higher than a slow walk.He has again begun rehab.Subsequent scans (type not mentioned) determined that no components are dislodged.Patient thought the rehab period would be 6 months and at the 3/4 month period he wasn't seeing much in the range of motion.However, upon speaking with physician he was achieving better results in the 3/4 month of physical therapy than what was typically expected.Patient described the pain as a "stress-bony" pain.All scans taken post op looked good.Patient went back to physical therapy but the pain persists.Patient feels the implant might not be securely attached, the functionality is fine but they feel some general numbness in their foot but are more concern about the pain as it seems to progressively get worst.Patient was a very active person and since the surgery has lost 20 lbs.
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Manufacturer Narrative
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The device is not available for evaluation as it remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.
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Search Alerts/Recalls
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