Catalog Number UNK_WWA |
Device Problems
Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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Patient Problems
Cyst(s) (1800); Loss of Range of Motion (2032); Inadequate Osseointegration (2646); Implant Pain (4561); Swelling/ Edema (4577)
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Event Date 01/04/2024 |
Event Type
Injury
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Manufacturer Narrative
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Based on the available information the device remains implanted 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 has always had medial pan and swelling since a total ankle replacement surgery.The patient has developed a cyst in the medial malleolus.Spect ct and ct demonstrate hot spot in this area ¿ they suggest implant is fixed ¿ but that there is impingement of the implant on the medial malleolus.The surgical plan would either be to graft the cyst in isolation ¿ or to consider a revision of the components if maligned.
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Event Description
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It was reported that the patient has always had medial pan and swelling since a total ankle replacement surgery.The patient has developed a cyst in the medial malleolus.Spect ct and ct demonstrate hot spot in this area ¿ they suggest implant is fixed ¿ but that there is impingement of the implant on the medial malleolus.The surgical plan would either be to graft the cyst in isolation ¿ or to consider a revision of the components if maligned.
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Manufacturer Narrative
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Correction: h6 device code the reported could be confirmed based on available medical record and medical expert assessment.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.No indications of material, manufacturing or design related problems were found during the investigation.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 talus shows some radiolucence and it looks subsided as well.Therefore loosening, as well as subsidence/migration can be confirmed." based on the investigation, the root cause was attributed to the patient related issue.The failure was detected due to some radiolucency and poor bone stock around the talus component which resulted in the subsidence of the implant.If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text : device not available.
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Search Alerts/Recalls
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