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Model Number HC-15120-03M |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Loss of Range of Motion (2032); Scar Tissue (2060)
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Event Date 10/06/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient was experiencing loss of mobility in their knee.The patient underwent a revision surgery on (b)(6) 2022.During the revision surgery, the surgeon identified scar tissue formation.The surgeon removed the scar tissue.The surgeon took out all of the implants besides the segmental stem, collar, locking ring, and tibial baseplate, and flashed these devices then re-implanted the devices.The surgeon scheduled another revision surgery on (b)(6) 2022 in order to revise some implants and perform a washout in order to prevent an infection.On (b)(6) 2022, the surgeon revised the following implants: distal femur axial pin, poly spacer, tibial hinge component, distal femur, and male-female midsection.No additional information regarding this event has been provided.
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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: #3013450937-2022-00305, #3013450937-2022-00306, #3013450937-2022-00307, #3013450937-2022-00308, #3013450937-2022-00309, #3013450937-2022-00310, #3013450937-2022-00311, #3013450937-2022-00312, #3013450937-2022-00314.
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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 adverse event 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 3221: no findings available.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 was experiencing loss of mobility in their knee.The patient underwent a revision surgery on (b)(6) 2022.During the revision surgery, the surgeon identified scar tissue formation.The surgeon removed the scar tissue.The surgeon took out all of the implants besides the segmental stem, collar, locking ring, and tibial baseplate, and flashed these devices then re-implanted the devices.The surgeon scheduled another revision surgery on (b)(6) 2022 in order to revise some implants and perform a washout in order to prevent an infection.On (b)(6) 2022, the surgeon revised the following implants: distal femur axial pin, poly spacer, tibial hinge component, distal femur, and male-female midsection.No additional information regarding this event has been provided.
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Search Alerts/Recalls
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