WRIGHT MEDICAL TECHNOLOGY INC INBONE EVERLAST SZ 2+ 8MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 22023208 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ambulation Difficulties (2544); Implant Pain (4561); Swelling/ Edema (4577)
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Event Date 12/14/2022 |
Event Type
Injury
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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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Event Description
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It was reported that the patient was walking with a limp, has pain, swelling in ankle and in unable to walk.The patient told the doctor and was provided support hose and those didn't make a difference.Patient requires a wheelchair at times to move around.
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Event Description
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It was reported that the patient was walking with a limp, has pain, swelling in ankle and in unable to walk.The patient told the doctor and was provided support hose and those didn't make a difference.Patient requires a wheelchair at times to move around.
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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.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.Pfa data was reviewed for the provided catalog.No pfa or recall were noted for this catalog and lot.Upon further investigation of the ct scans and radiology reports by healthcare professionals the following was observed "in the available radiology reports there are no issues noted regarding the implant.Furthermore, the provided ct scans show only preoperative condition (primary surgery) hence the cause of failure remains unknown. therefore, 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." 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.If device is returned or any further information is provided, the investigation report will be reassessed.
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Search Alerts/Recalls
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