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Model Number FB-19152-03M |
Device Problem
Migration (4003)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/19/2022 |
Event Type
Injury
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Event Description
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It was reported that a patient was revised due to an eleos canal filling stem which loosened over time.The patient's index surgery was on (b)(6) 2019, where the patient was implanted with the canal filling stem, a male-female midsection, and a custom adaptor.The patient was revised on (b)(6) 2022 to remove and replace the canal filling stem and male-female midsection.The custom adaptor was left implanted.This event will be reportable to the fda as a serious injury due to the revision procedure.No alleged issues occured with the male-female midsection and the custom adaptor; therefore, these devices are concomitant.
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Event Description
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It was reported that a patient was revised due to an eleos canal filling stem which loosened over time.The patient's index surgery was on (b)(6) 2019, where the patient was implanted with the canal filling stem, a male-female midsection, and a custom adaptor.The patient was revised on 19 april 2022 to remove and replace the canal filling stem and male-female midsection.The custom adaptor was left implanted.This event will be reportable to the fda as a serious injury due to the revision procedure.No alleged issues occured with the male-female midsection and the custom adaptor; therefore, these devices are concomitant.
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Manufacturer Narrative
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It was reported that a patient experienced loosening of an eleos canal filling segmental stem.The patient was revised on 19 april 2022, to remove and replace the loosened canal filling segmental stem.The surgeon revised the 19x152mm canal-filling bowed segmental stem to a 21x152mm canal-filling bowed segmental stem.During the revision procedure, the eleos male-female midsection was revised as well.There were no alleged issues reported with the male-female midsection; therefore, this device will be considered concomitant.A review of the work order and sterilization batch release record for the product involved found no indication that the implant loosening was a result of a manufacturing or sterilization nonconformance.A complaint trend was not identified.The root cause for the canal-filling segmental stem loosening could not be determined.Based upon the review of the device history records and sterilization records, the investigation concluded that the root cause of the canal-filling segmental stem loosening was not related to the design, manufacturing, and/or sterilization of the components.The root cause of the canal-filling segmental stem loosening could not be determined.From the submitted intake form, it was reported that the patient was compliant and had medium activity levels, however, the patient had poor bone quality.It is possible that loosening could have occurred due to insufficient healing, residual post-operative motion, etc.However, a root cause could not be determined based on the available information.
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Search Alerts/Recalls
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