WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN INFINITY TIBIAL COMPONENT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number UNK_WWA |
Device Problems
Insufficient Information (3190); Migration (4003)
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Patient Problems
Cyst(s) (1800); Insufficient Information (4580)
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Event Date 12/02/2022 |
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.A review of the device history is not possible because the lot number was not communicated.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.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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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, since review of the provided ct imaging confirms that a revision surgery is likely needed.Medical affairs was consulted on the details of the investigation.According to their review, "both tibial and talar components show at least discrete signs of loosening with the cysts below the implants.The signs are clearer and more convincing in the talus.The pe can only be assessed indirectly, however, the seem to be in place and intact.".Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by the development of cysts around the devices resulting in loosening.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling was not possible because the catalog number and lot number were not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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