Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/11/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Device is the rosa robot.
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Event Description
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It was reported that anterior notching was observed after an initial knee arthroplasty.During the procedure notching occurred during the 4-in-1 anterior cut.Surgeon stopped advancing anterior cut and used a rongeur instrument to chip away bone.Component notched approximately 3mm.No intervention was needed.Patient was reported to be happy and ok at initial follow up visit.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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No additional information on the reported event.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Post-op x-ray images of the operated knee confirmed the reported event of the rosa knee system procedure resulting in a notching of the femur.Review of the dhr for the rosa recon platform 220v (20-8020-100-26 kn20404) identified no deviations or anomalies related to the reported event.The rosa knee system software application log files were sent back for investigation.Investigation of the log files by a software sme found the following: no system errors detected in logs.The system was found to have performed as expected.No problem with registration: 6-pts registration and cut guide checkpoint succeeded on the first attempt.The validation was performed while still in the cut panel, and was consistent with planning.There was no apparent issue during the automatic robot positioning and engage step before pinning.The live values at pin step were already slightly lower than planned (about 1mm).The live values after cut step were lower (about 1.5mm lower than planned).Landmarking of the anterior cortex was towards the bone sulcus rather than on the higher side of the lateral ridge the rosa recon platform s/n kn20404 was evaluated on site by a field service engineer (fse) and found no fault with the system.Based on the available information, contributing factors/probable causes include the following: landmarking of the anterior cortex towards the bone sulcus rather than on the higher side of the lateral ridge.Intraoperative planning involving a very low stylus height (0.7mm), while the rated precision of the system is ±2mm.Cut guide instability leading to a posterior shift during the 4-in-1 hole drilling step.Movement of the camera between the six-point registration and the cuts (can slightly reduce the accuracy of the system).A definite root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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