Model Number 25001210E |
Device Problems
Disassembly (1168); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915); Migration (4003)
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Patient Problems
Patient Problem/Medical Problem (2688); No Information (3190)
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Event Date 05/22/2018 |
Event Type
Injury
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Manufacturer Narrative
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This report is for one of two devices involved in the event, please refer to report 3013450937-2018-000011 for the other.The device history records and sterilization batch release records were reviewed and indicated that all components involved met specification.The operation notes and patient x-rays were requested along with the explanted components.The tibial poly spacer had been returned for further analysis and all other components involved were not revised.This investigation is currently ongoing and should additional information be obtained the report will be supplemented.
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Event Description
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The patient presented with a dislocated hinge component, which required surgical intervention.During the revision surgery it was found that the tibial poly spacer disengaged and migrated to the surface of the knee.
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Manufacturer Narrative
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This report is for one of two devices involved in the event, please refer to report 3013450937-2018-00011 for the other.Based upon the patient information, device history review, and the returned product evaluation it can be concluded that the failure was not related to the manufacture of the implants or a non-conformance and this complaint has been closed.Should additional information be obtained, the complaint will be re-opened and the report will be supplemented.
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Event Description
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The patient presented with a dislocated hinge component, which required surgical intervention.During the revision surgery it was found that the tibial poly spacer disengaged and migrated to the surface of the knee.
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Search Alerts/Recalls
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