Model Number THSMWOS01M |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Fluid Discharge (2686)
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Event Date 10/04/2021 |
Event Type
Injury
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Manufacturer Narrative
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The investigation is in process.The device will not be returned for evaluation.When the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdrs were submitted for this event: #3013450937-2021-00237, #3013450937-2021-00238, #3013450937-2021-00239, #3013450937-2021-00240, #3013450937-2021-00241, #3013450937-2021-00242, #3013450937-2021-00244, #3013450937-2021-00245.
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Event Description
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It was reported that the patient underwent a revision surgery on (b)(6) 2021 due to an alleged infection.The patient's knee was discharging fluid and the surgeon wanted to test for an infection.During the revision surgery, the surgeon performed a poly swap and a washout.The following eleos implants were revised during the revision surgery: 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 segmental stem, tibial baseplate, cemented stem extension, and resurfacing patella.No additional information regarding this event has been provided.
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Event Description
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It was reported that the patient underwent a revision surgery on (b)(6) 2021 due to an alleged infection.The patient's knee was discharging fluid and the surgeon wanted to test for an infection.During the revision surgery, the surgeon performed a poly swap and a washout.The following eleos implants were revised during the revision surgery: 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 segmental stem, tibial baseplate, cemented stem extension, and resurfacing patella.No additional information regarding this 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: 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.
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Search Alerts/Recalls
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