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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
Implant Pain (4561)
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Event Date 04/28/2023 |
Event Type
Injury
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Event Description
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A review of study report of retrospective data collection intended to collect safety and performance on subjects that have been previously implanted with the ¿biofoam wedge system' revealed that, ¿one patient had persistent pain at the sinus tarsi, solved with arthroereisis removal after 1 year¿.
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Manufacturer Narrative
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The reported event that patient required removal of device due to persistent pain at the sinus tarsi, could not be confirmed, since the device(s) were not returned for evaluation and no other additional information was received from the clinical site.More detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause. if any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.
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Event Description
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A review of study report of retrospective data collection intended to collect safety and performance on subjects that have been previously implanted with the ¿biofoam wedge system' revealed that, ¿one patient had persistent pain at the sinus tarsi, solved with arthroreisis removal after 1 year¿.
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Manufacturer Narrative
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This complaint has been generated based on findings discovered during the post-market surveillance literature review.The alleged event of a ¿pain treated with additional surgery¿ could not be confirmed, since no additional information was received from the author or the article.More detailed information about the patient medical history, the event circumstances, and medical reports must be available to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.
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Search Alerts/Recalls
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