Model Number 25002111E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Post Operative Wound Infection (2446)
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Event Date 10/31/2021 |
Event Type
Injury
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Manufacturer Narrative
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The investigation is in process.Once the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdrs have been submitted for this adverse event: #3013450937-2021-00302, #3013450937-2021-00303, #3013450937-2021-00304, #3013450937-2021-00305, #3013450937-2021-00306, #3013450937-2021-00307, #3013450937-2021-00308.
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Event Description
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It was reported that the patient developed an alleged wound infection and underwent a revision surgery on (b)(6) 2021.During the revision surgery, the following eleos implants were revised: tibial hinge component, distal femur axial pin, and tibial poly spacer.The following eleos implants remain implanted from the patient's original surgery: distal femur, male-female midsection, cemented stem extension, tibial baseplate, and cemented segmental stem.The surgeon performed a washout.No additional information regarding this adverse event has 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 root cause of the alleged infection could not be determined.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: b4: date of this report added.G3: date received by manufacturer added.G6: type of report added.H2: follow-up type added.H3: device evaluated by manufacturer updated to no.H6: type of investigation code updated to 3331: analysis of production records.H6: type of investigation code updated to 4111: communication/interviews.H6: type of investigation code updated to 4110: trend 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 4109: historical data analysis.H6: investigation findings code updated to 213: no device problem found.H6: investigation conclusions code updated to 4315: cause not established.H10: additional narratives/data.
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Event Description
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It was reported that the patient developed an alleged wound infection and underwent a revision surgery on (b)(6) 2021.During the revision surgery, the following eleos implants were revised: tibial hinge component, distal femur axial pin, and tibial poly spacer.The following eleos implants remain implanted from the patient's original surgery: distal femur, male-female midsection, cemented stem extension, tibial baseplate, and cemented segmental stem.The surgeon performed a washout.No additional information regarding this adverse event has been provided.
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Search Alerts/Recalls
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