Correction: d4 lot, g1 reporting entity, contact.The reported event could be not confirmed.The device was returned for evaluation and functional testing could not confirm the alleged failure mode as the device was found to function as intended.The device inspection revealed the following: visual inspection a visual inspection of the returned stem revealed slight surface scratches and rub marks.Overall, the stem looked to be in excellent condition.Functional inspection: the r&d engineer performed a functional test on the returned stem and a spare poly device.The functional testing revealed that a spare polyethylene component assembly was able to be assembled into the stem that was returned without issue.The spare poly assembled without issue when following the surgical technique.A review of the device history for the reported lot did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on analysis of the returned component and provided information, the root cause was attributed to user related issue.The most likely cause of the reported difficulty is due to the user not applying thumb pressure to the polyethylene component prior to impaction.The surgical technique instructs the user to ¿apply hand pressure to begin to engage the locking mechanism.¿ if any additional information is provided, the investigation will be reassessed.
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