WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN INFINITY TIBIAL COMPONENT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number UNK_WWA |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/07/2022 |
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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Manufacturer Narrative
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The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.Formal medical opinion was sought from an experienced independent medical expert and he opined as below- ¿the ct-scan shows tar in place.No signs of loosening/osteolysis/large cysts.Implants looks intact and well-fixed to the bone.Without further clinical information the indication for revision is cannot be determined.¿ 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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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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