Model Number 25001210E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Unspecified Infection (1930)
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Event Date 08/05/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient fell and opened their incision.The patient underwent a revision surgery on (b)(6) 2022.The surgeon performed incision and drainage and revised the following implants: poly spacer, distal femur axial pin, and tibial hinge component.The following implants remain implanted from the patient's original surgery: distal femur, tibial baseplate, cemented stem extension, and canal-filling segmental stem.No additional information 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: #3013450937-2022-00229; #3013450937-2022-00230; #3013450937-2022-00231; #3013450937-2022-00232; #3013450937-2022-00233; #3013450937-2022-00234.
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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 fall and 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.
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Event Description
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It was reported that the patient fell and opened their incision.The patient underwent a revision surgery on (b)(6) 2022.The surgeon performed incision and drainage and revised the following implants: poly spacer, distal femur axial pin, and tibial hinge component.The following implants remain implanted from the patient's original surgery: distal femur, tibial baseplate, cemented stem extension, and canal-filling segmental stem.No additional information has been provided.
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Search Alerts/Recalls
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