STRYKER GMBH TIBIAL COMP,SINGLECOATED US VERSION, MEDIUM; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
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Model Number 400-262 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Impaired Healing (2378)
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Event Date 07/15/2015 |
Event Type
Injury
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
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Event Description
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As reported: "i had issues with the star ankle replacement as soon as it was put in.The center piece kept breaking and causing fractures.I had multiple revisions and had to have my leg amputated." per medical records received from the patient on (b)(6) 2021 the event is as follow: (b)(6) 2015 : anterior ankle arthrotomy with removal of total ankle implant with bone culture and biopsy.¿ 5th intervention.
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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 medical opinion of a medical expert was requested based on the provided patient documents that we have received.About this complaint, the medical expert explained that: (b)(6)2015 : anterior ankle arthrotomy with removal of total ankle implant with bone culture and biopsy.¿ 5th intervention wound healing problems remain and need revision." this statement allowed us to determine that this complaint is about an infection case.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 infection.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 material, manufacturing or design related problems were found during the investigation.If any further information is provided, the complaint report will be updated.
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Event Description
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As reported: "i had issues with the star ankle replacement as soon as it was put in.The center piece kept breaking and causing fractures.I had multiple revisions and had to have my leg amputated." per medical records received from the patient on (b)(6), 2021 the event is as follow: (b)(6) 2015 : anterior ankle arthrotomy with removal of total ankle implant with bone culture and biopsy.¿ 5th intervention.
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