WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN_WRIGHT MEDICAL-ARLINGTON_PRODUCT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number UNK_WWA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 06/15/2022 |
Event Type
Injury
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Manufacturer Narrative
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Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed. 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.
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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 that are not available at the time of this report.
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Manufacturer Narrative
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The reported event could be confirmed with the help of evidences provided by the customer.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: ¿improper selection, placement, positioning, and fixation of the prosthetic components may result in unusual stress conditions and a subsequent reduction in service life of the prosthetic component.Periodic, long-term follow-up is recommended to monitor the position and state of the prosthetic components, as well as the condition of the adjoining bone.¿.Formal medical opinion was sought from an experienced independent medical expert as below; ¿the ct-slices show radiolucencies especially in the rea of the tibial implant and around the screw that was placed in the medial malleolus.Both are indicative for loosening of the implant.¿ more clinical information as well as the retrieved implant are necessary to determine the exact root cause.If device is returned or any further information is provided, the investigation report will be reassessed.
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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 that are not available at the time of this report.
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Search Alerts/Recalls
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