WRIGHT MEDICAL TECHNOLOGY INC INFINITY¿ TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 33652208 |
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 12/09/2020 |
Event Type
Injury
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
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Event Description
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It was reported that the patient continued to have pain in the ankle following the surgery.Ct showed no evidence of significant loosening of the implants.Suspect bony impingement as likely cause of pain.Patient also noted to have end-stage talonavicular arthritis.Revision surgery took place to revise ankle implant with poly exchange and gutter cleanout, talonavicular joint fusion with calcaneus bone graft harvest.Subject continuing to improve since poly exchange surgery, follow-up yearly.
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
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Event Description
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It was reported that the patient continued to have pain in the ankle following the surgery.Ct showed no evidence of significant loosening of the implants.Suspect bony impingement as likely cause of pain.Patient also noted to have end-stage talonavicular arthritis.Revision surgery took place to revise ankle implant with poly exchange and gutter cleanout, talonavicular joint fusion with calcaneus bone graft harvest.Subject continuing to improve since poly exchange surgery, follow-up yearly.
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Event Description
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It was reported that the patient continued to have pain in the ankle following the surgery.Ct showed no evidence of significant loosening of the implants.Suspect bony impingement as likely cause of pain.Patient also noted to have end-stage talonavicular arthritis.Revision surgery took place to revise ankle implant with poly exchange and gutter cleanout, talonavicular joint fusion with calcaneus bone graft harvest.Subject continuing to improve since poly exchange surgery, follow-up yearly.
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Manufacturer Narrative
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The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.There are many clinical factors that can affect the results of any surgery, such as surgical technique, pre-operative and post-operative care, the implant, patient pathology and daily activity.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
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