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Model Number 25000007E |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
Fall (1848)
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Event Date 04/25/2022 |
Event Type
Injury
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Manufacturer Narrative
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The investigation is in process.When the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdrs were submitted for this event: 3013450937-2022-00168.
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Event Description
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It was reported that the patient fell for an unknown reason and the distal femur dissociated from the canal-filling segmental stem.The patient underwent a revision surgery on (b)(6) 2022 where the following implants were revised: distal femur, distal femur axial pin, tibial hinge component, poly spacer, and proximal tibia.No additional information regarding this event have been provided.
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Event Description
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It was reported that the patient fell for an unknown reason and the distal femur dissociated from the canal-filling segmental stem.The patient underwent a revision surgery on (b)(6) 2022 where the following implants were revised: distal femur, distal femur axial pin, tibial hinge component, poly spacer, and proximal tibia.No additional information regarding this event have been provided.
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Manufacturer Narrative
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This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The device history records and sterilization batch records were reviewed and no issues during manufacturing or sterilization were identified that would have contributed to this complaint.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: h3: device evaluated by manufacturer updated to no.H6: type of investigation code updated to 4110: trend analysis.H6: type of investigation code updated to 4109: historical data analysis.H6: type of investigation code updated to 4114: device not returned.H6: type of investigation code updated to 4117: device not accessible for testing.H6: type of investigation code updated to 3331: analysis of production records.H6: investigation findings code updated to 213: no device problem found.H6: investigation conclusions code updated to 4315: cause not established.
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Search Alerts/Recalls
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