WRIGHT MEDICAL TECHNOLOGY INC INFINITY POLY SZ 3 8MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 33653308 |
Device Problems
Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cyst(s) (1800); Osteopenia/ Osteoporosis (2651); Implant Pain (4561); Swelling/ Edema (4577)
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Event Date 11/19/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient has noticed pain and swelling of the ankle, 6 years post-op of a total ankle replacement.Ct scans show cystic changes in the tibia and talus with loss of bone density.It is possible that the patient may undergo a revision with removal of implants and changing to a ankle fusion with cadaver bone.Currently, the patient can walk on the ankle but wears a boot to limit the "shearing" action to the ankle.
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Manufacturer Narrative
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Device is not available to be returned as it remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.
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Manufacturer Narrative
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The reported event could be confirmed based on available medical record and medical expert assessment.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Medical records and the radiology reports were also reviewed by the hcp, and there is nothing that really stands out, other than the cyst formation around implant in both tibia and talus.Upon further investigation of the ct scans by healthcare professionals the following was observed ¿all tar components look intact.There is significant periprosthetic cyst formation as well in the tibia as in the talus, which is an indication for revision (such bone loss is frequently progressive)¿ based on the investigation the root cause can be attributed to the patient related issue.The failure was caused due to significant periprosthetic cyst formation in tibia as well as talus which is an indication for revision.Also, all the tar components are assessed as fixed by the hcp.If device is returned or any further information is provided, the investigation report will be reassessed.
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Event Description
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It was reported that the patient has noticed pain and swelling of the ankle, 6 years post-op of a total ankle replacement.Ct scans show cystic changes in the tibia and talus with loss of bone density.It is possible that the patient may undergo a revision with removal of implants and changing to a ankle fusion with cadaver bone.Currently, the patient can walk on the ankle but wears a boot to limit the "shearing" action to the ankle.
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Search Alerts/Recalls
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