STRYKER GMBH TALAR COMP,SINGLE COATED US VERS X-SMALL, LEFT; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
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Catalog Number 400253 |
Device Problem
Device Slipped (1584)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/20/2018 |
Event Type
Injury
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Manufacturer Narrative
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Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Still implanted.
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Event Description
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It was reported from the clinical team that the subject received a star in the left ankle on (b)(6) 2017.On (b)(6) 2018, subject presented with left talar subsidence with subtalar cystic change resulting in device subsidence.The clinical investigator deems this ae as severe and related to the device.The subject is expected to receive surgical intervention for her left ankle in the coming months.
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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.More detailed information about the complaint event as well as the affected device and medical records must be available in order to determine the root cause of the complaint event.The device inspection was not possible as the product was not returned for investigation.Cysts (osteolysis), pain and implant dislocations are listed as adverse effects in the ifu; furthermore, a warning regarding activities like running and jumping as a potential cause for implant failures.In addition, patient has a bmi of 43.9 and is obese.The misalignment was most likely caused by the cysts.A correlation between the implants and the cyst cannot be excluded.Cysts and implant dislocations are classified as known adverse effect.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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Event Description
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It was reported from the clinical team that the subject received a star in the left ankle on (b)(6) 2017.On (b)(6) 2018, subject presented with left talar subsidence with subtalar cystic change resulting in device subsidence.The clinical investigator deems this ae as severe and related to the device.The subject is expected to receive surgical intervention for her left ankle in the coming months.
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Search Alerts/Recalls
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