WRIGHT MEDICAL TECHNOLOGY INC INFINITY EVERLAST SZ 3 6MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 33683306 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nerve Damage (1979); Implant Pain (4561)
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Event Date 10/17/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a total ankle replacement.The patient presented with nerve pain at the right ankle.The treatment involved the effected leg being placed in short leg cast, ice, elevate.Overall, patient is healing and doing well post-operatively.Treatment included medication and increased activity.Healing and progressing well postoperatively.Nerve pain should continue to improve.Treatment included medication and viscose pad for shoe.
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.H3 other text : device remains implanted in patient.
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Manufacturer Narrative
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The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection revealed the following: a device inspection was not possible since the affected device was not returned and no other evidences were provided 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.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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Event Description
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It was reported that the patient underwent a total ankle replacement.The patient presented with nerve pain at the right ankle.The treatment involved the effected leg being placed in short leg cast, ice, elevate.Overall, patient is healing and doing well post-operatively.Treatment included medication and increased activity.Healing and progressing well postoperatively.Nerve pain should continue to improve.Treatment included medication and viscose pad for shoe.
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