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Model Number FS-21120-03M |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Event Description
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It was reported that an eleos segmental stem loosened approximately 8 months post operatively.The patient underwent their index procedure on 02 march 2022, where the patient was implanted with the following devices: eleos canal filling stem, distal femur axial pin, tibial hinge, poly spacer, stem extension, distal femur, tibial baseplate, and a tibial baseplate tapered screw.During the patient's revision procedure on 23 november 2022, the loosened 21mm x 120mm canal filling stem was removed and replaced with a 15mm x 152mm cemented stem.The following devices were also replaced: poly spacer, distal femur, distal femur axial pin, and a tibial hinge.No issues were reported for these replaced devices.This event will be reportable to the fda as a serious injury due to the revision procedure.
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Manufacturer Narrative
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It was reported that a patient's 21x120mm canal filling segmental stem had loosened.The patient underwent a revision surgery on 23 november 2022 where the surgeon revised the patient's 21x120mm eleos canal filling segmental stem to a 15x152mm cemented bowed segmental stem.The surgeon also revised the eleos poly spacer, eleos tibial hinge component, eleos distal femur axial pin, and eleos distal femur.There were no alleged malfunctions with the poly spacer, tibial hinge component, distal femur axial pin, and distal femur.Device history records were reviewed and no abnormalities were identified.It is possible that the alleged loosening could have occurred due to insufficient healing, residual post-operative motion, etc.However, as additional information regarding this event is not known, the root cause of this event could not be identified.
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Search Alerts/Recalls
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