WRIGHT MEDICAL TECHNOLOGY, INC. INBONE¿ TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 200347901 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Failure of Implant (1924); Insufficient Information (4580)
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Event Date 05/13/2022 |
Event Type
Injury
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Manufacturer Narrative
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Device is not available 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 the implant is loose and the patient will undergo a revision surgery.
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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.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.The current instructions for use states: "dislocation and subluxation of prosthetic components can result from improper positioning and/ or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.Prosthetic components can loosen or migrate due to trauma or loss of fixation." 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.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 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 implant is loose and the patient will undergo a revision surgery.
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Search Alerts/Recalls
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