WRIGHT MEDICAL TECHNOLOGY INC INFINITY¿ ADAPTIS TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 33680024 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Wound Dehiscence (1154)
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Event Date 06/16/2021 |
Event Type
Injury
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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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Event Description
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It was reported that during an office evaluation it was found that the patient had mild wound dehiscence in the mid portion incisional area.Minimal serosanguineous drainage noted.The patient underwent a revision surgery in which the surgeon took multiple cultures, performed irrigation debridement of the wound and swapped out the poly.A negative pressure wound therapy was applied over small area of wound dehiscence.
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Manufacturer Narrative
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Correction h6 health impact code.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.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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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Event Description
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It was reported that during an office evaluation it was found that the patient had mild wound dehiscence in the mid portion incisional area.Minimal serosanguineous drainage noted.The patient underwent a revision surgery in which the surgeon took multiple cultures, performed irrigation debridement of the wound and swapped out the poly.A negative pressure wound therapy was applied over small area of wound dehiscence.
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