Model Number 33650005 |
Device Problems
Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Failure of Implant (1924); Insufficient Information (4580)
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Event Date 12/02/2021 |
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 the patient underwent a total ankle replacement surgery.Allegedly the patient may need to undergo a revision surgery due to reasons that were not available.
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Event Description
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It was reported that the patient underwent a total ankle replacement surgery.Allegedly the patient may need to undergo a revision surgery due to medial mal integrity and tibial tray loosening.
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Manufacturer Narrative
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The reported event could be confirmed with the help of the ct scans provided for investigation.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.The instructions for use instructs user that: ¿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.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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