Catalog Number UNK_SEL |
Device Problems
Break (1069); Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Failure of Implant (1924); Joint Laxity (4526); Implant Pain (4561); Insufficient Information (4580)
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Event Date 06/20/2022 |
Event Type
Injury
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Manufacturer Narrative
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The information in this report was provided by stryker legal affairs department.No additional information is available currently due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
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Event Description
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It was reported by the patient's attorney as a result of a legal claim that allegedly the patient was implanted with a scandinavian total ankle replacement (star) device.It is further alleged that he suffered personal injuries as a result of the implantation.
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Manufacturer Narrative
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Please note the corrections to b1, h6 device and h6 clinical signs codes.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 (such as the cat# and lot# of the device) as well as the affected device, and the patient information / activity levels must be available in order to determine the root cause of the complaint event.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 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.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 by the patient's attorney as a result of a legal claim that allegedly the patient was implanted with a scandinavian total ankle replacement (star) device.It is further alleged that he suffered personal injuries as a result of the implantation.Additional information: it was reported through the filing of a lawsuit that allegedly the patient was implanted with a stryker star ankle on (b)(6) 2014.Subsequently, the patient experienced progressive symptoms of pain and instability in his affected ankle.It is further alleged that the star implants polyethylene component material degraded causing it to fracture.
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Search Alerts/Recalls
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