The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the received device (proximal body) when inspected visually looks in good condition and shows no signs of damage.Moreover, the functional inspection was done by assembling the returned devices and it was observed the whole construct is intact & tightened, there were no signs of loosening.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labelling did not indicate any abnormalities.Based on investigation, the probable root cause was attributed to a patient related issue.As there are multiple patient related factors such as bone condition, activity level, and/or compliance to post-surgical instructions that can contribute to component loosening.If any further information is provided, the complaint report will be updated.
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