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Model Number 25000007E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 03/29/2022 |
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: 3013450937-2022-00142, 3013450937-2022-00143, 3013450937-2022-00145, 3013450937-2022-00146, 3013450937-2022-00147, 3013450937-2022-00148, 3013450937-2022-00149, 3013450937-2022-00150, 3013450937-2022-00151.
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Event Description
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It was reported that the patient developed an alleged infection.The patient underwent a revision surgery to washout their proximal femoral replacement system.The patient underwent another revision surgery to washout their distal femoral replacement system and revise the tibial hinge component, poly spacer, and distal femur axial pin.The patient underwent another revision surgery where all implants were revised.The following implants were revised: male-male midsection, male-female midsection, poly spacer, tibial hinge component, distal femur axial pin, proximal femur, and distal femur.No additional information regarding this adverse event has been reported.
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Event Description
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It was reported that the patient developed an alleged infection.The patient underwent a revision surgery to washout their proximal femoral replacement system.The patient underwent another revision surgery to washout their distal femoral replacement system and revise the tibial hinge component, poly spacer, and distal femur axial pin.The patient underwent another revision surgery where all implants were revised.The following implants were revised: male-male midsection, male-female midsection, poly spacer, tibial hinge component, distal femur axial pin, proximal femur, and distal femur.No additional information regarding this adverse event has been reported.
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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.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 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: investigation findings code updated to 3221: no findings available.H6: investigation conclusions code updated to 4315: cause not established.H10: additional narratives/data.
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Search Alerts/Recalls
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