Model Number CS-13120-03M |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 06/27/2022 |
Event Type
Injury
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Manufacturer Narrative
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It was reported that the patient developed an alleged infection and underwent a revision surgery on (b)(6) 2022.During the revision surgery, the surgeon revised the tibial hinge component, distal femur axial pin, and tibial poly spacer.The following eleos implants remain implanted from the patient's surgery on (b)(6) 2022: distal femur, male-female midsection, cemented segmental stem, canal-filling segmental stem, tibial baseplate, two tibial block augments, and a cemented stem extension.A review of the work orders and sterilization batch release records for the products involved found no indication that the alleged infection was a result of a manufacturing or sterilization nonconformance.The root cause identified for this complaint is an alleged infection, which required surgical intervention.The root cause of the patient's alleged infection could not be determined.Ultimately, based upon the device history records, sterilization records, and interview with the regional sales manager the investigation concluded that the root cause of the alleged infection is not related to the design, manufacture, and/or sterilization of the components.
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Event Description
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It was reported that a patient underwent revision surgery for a poly swap of eleos implants.It is likely that the patient's implanted eleos distal femur axial pin, eleos tibial hinge components, and eleos polyspacer were removed and replaced.On 23 september 2022, additional information was received regarding this event: it was reported that the patient developed an alleged infection and underwent a revision surgery on (b)(6) 2022.During the revision surgery, the surgeon revised the tibial hinge component, distal femur axial pin, and tibial poly spacer.The following eleos implants remain implanted from the patient's surgery on (b)(6) 2022: distal femur, male-female midsection, cemented segmental stem, canal-filling segmental stem, tibial baseplate, two tibial block augments, and a cemented stem extension.All parts implanted at the time of infection will be reported.This event will be reported to the fda as a serious injury due to the revision.This record captures the eleos cemented segmental stem.
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Search Alerts/Recalls
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