Catalog Number UNK_WWA |
Device Problems
Unstable (1667); Malposition of Device (2616); Osseointegration Problem (3003); Migration (4003)
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Patient Problems
Bone Fracture(s) (1870); Inadequate Osseointegration (2646); Limb Fracture (4518)
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Event Date 03/01/2023 |
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.H3 other text : device remains implanted in patient.
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Event Description
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It was reported that the patient may need to undergo a revision surgery due to "initial malalignment of the tibia and/or early periprosthetic fracture/collapse of the lateral tibia allowing it to subside.The tibia certainly needs revising to an implant with stem to increase stability.The talus may be stable and might ordinarily be possible to retain but obviously that would make cannulation of the tibial canal impossible and so i believe the whole construct will need revision to invision tibia plus inbone or invision talus.".
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Manufacturer Narrative
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The reported event could be confirmed, based on available medical records and experts opinions.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.Upon further investigation of the ct scans by healthcare professionals the following was observed - the periprosthetic fracture pattern with a compression zone at the lateral side of the tibial pylon, it is most likely that most malalignment is a result of this fracture malunion.It is confirmed by the proper alignment between tibial and talar component that has stayed intact.Malalignment of implant is caused by malunion of fracture which is not healed in the correct anatomical position.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by poor bone quality.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 may need to undergo a revision surgery due to "initial malalignment of the tibia and/or early periprosthetic fracture/collapse of the lateral tibia allowing it to subside.The tibia certainly needs revising to an implant with stem to increase stability.The talus may be stable and might ordinarily be possible to retain but obviously that would make cannulation of the tibial canal impossible and so i believe the whole construct will need revision to invision tibia plus inbone or invision talus.".
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Search Alerts/Recalls
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