WRIGHT MEDICAL TECHNOLOGY INC INFINITY¿ TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 33650013 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cyst(s) (1800); Insufficient Information (4580)
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Event Date 06/20/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a total ankle replacement.Allegedly, the patient may need to undergo a revision surgery for reasons not available at the time of this report.
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Manufacturer Narrative
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The device is not available for inspection as it remains implanted in the patient.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.The suspect device was not identified, therefore, the manufacturer cannot determine the suspect device.However, other suspect devices in use are # 33653206 and # 33630022.
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Event Description
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It was reported that the patient underwent a total ankle replacement.Allegedly, the patient may need to undergo a revision surgery for reasons not available at the time of this report.
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Manufacturer Narrative
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Correction - h6 (clinical code, results & conclusion codes).The reported event could be confirmed with the help of the medical documents received.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.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.¿ formal medical opinion was sought from an experienced independent medical expert as below.¿it is a post-traumatic situation after a distal tibial fracture, treated surgically with 3 screws.This is a complex case.There is not sufficient information to assess the quality of the overall medical treatment.There are large periprosthetic cysts around both the tibial and talar components, that most likely are the main indication for revision surgery.The joint space appears to be symmetrical with a normal thickness of the pe-liner, making it less likely to be the indication for revision surgery.Patient-related factor is the most likely cause of failure (the formation of large bone cysts).¿ based on investigation, the root cause was primarily attributed to patient factors related issue.The failure was caused due to the formation of large bone cysts around both the tibial and talar components.The joint space appears to be symmetrical with a normal thickness of the pe-liner, making it less likely that excessive wear or breakage of the pe-liner would be the indication for revision surgery.If device is returned or any further information is provided, the investigation report will be reassessed.
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