Model Number CS-17120-03M |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Insufficient Information (4580)
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Event Type
Injury
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Event Description
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A patient was implanted with the eleos proximal tibia replacement system on (b)(6) 2019.On (b)(6) 2022, over two years post-operatively, the patient was revised.It was reported that the patient's eleos straight cemented stem had dissociated from the eleos resurfacing femur.The following implants were implanted on (b)(6) 2019: eleos male-female midsection, eleos cemented straight stem, eleos tibial hinge component, eleos tibial poly spacer, eleos proximal tibia, eleos resurfacing femur, eleos resurfacing femur axial pin, and eleos stem extension.During the patient's revision surgery on (b)(6) 2022 the following implants were placed: eleos stem extension, eleos tibial poly spacer, eleos distal femur axial pin, eleos distal femur, eleos segmental stem, eleos locking ring, eleos male femal midsection, and eleos tibial hinge.No issues were reported against the remaining devices.This event will be reportable to the fda as a serious injury.This report captures the dissociated eleos resurfacing femur.
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Event Description
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A patient was implanted with the eleos proximal tibia replacement system on (b)(6) 2019.On (b)(6) 2022, over two years post-operatively, the patient was revised.It was reported that the patient's eleos straight cemented stem had dissociated from the eleos resurfacing femur.The following implants were implanted on (b)(6) 2019: eleos male-female midsection, eleos cemented straight stem, eleos tibial hinge component, eleos tibial poly spacer, eleos proximal tibia, eleos resurfacing femur, eleos resurfacing femur axial pin, and eleos stem extension.During the patient's revision surgery on (b)(6) 2022 the following implants were placed: eleos stem extension, eleos tibial poly spacer, eleos distal femur axial pin, eleos distal femur, eleos segmental stem, eleos locking ring, eleos male femal midsection, and eleos tibial hinge.No issues were reported against the remaining devices.This event will be reportable to the fda as a serious injury.This report captures the dissociated eleos resurfacing femur.(b)(6) 2023 update: adiitional information was received and it was determined that the patient's eleos stem extension had disassociated from the eleos resurfacing femur, not the eleos straight cemented stem.
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Manufacturer Narrative
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A patient was implanted with the eleos proximal tibia replacement system on (b)(6) 2019.On (b)(6) 2022, over two years post-operatively, the patient was revised.It was reported that the patient's eleos cemented stem extension had dissociated from the eleos resurfacing femur.The devices were not returned for evaluation.As the devices were implanted for approximately two years, it is possible that residual post-operative motion could have contributed to the issue.However, the root cause for the dissociation could not be determined definitively.Two mfrs were reported due to this event: 3013450937-2023-00400; 3013450937-2023-00401.
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Search Alerts/Recalls
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