Requests for the explanted prosthesis and for additional information surrounding this event have been made.However, to date neither the device nor the information has been received.Without the benefit of analyzing the explant and without the requested information, quality cannot comment on the condition of the device or the events surrounding this incident.If the explanted device or additional information is received, quality will re-evaluate this event in accordance with procedures.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.A review of the complaint history database revealed no additional complaints for lot 2415922.Review of nonconforming reports revealed no nonconformance's for this lot.No capas are associated with this lot.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information, and because the device is not available for evaluation, no further corrective action is required at this time.
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