(b)(4).The associated complaint devices were not returned.The patient underwent a left total hip arthroplasty five years ago and reported back for trochanteric bursitis one month later.This was likely related to her procedure.She was successfully treated with anti-inflammatory medication and pain control.Patient remained in the study to date and has had no further complication or complaint with her left hip.Clinical investigation concluded a medical assessment is not required for this patient.A review of manufacturing records for product the liner and head screw (10fm03033 and 08lt25649) did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of the manufacturing records for the shell and oxinium femoral head (10fm16796 and 09em09395) revealed discrepancies during the manufacturing process; however these discrepancies were identified as not related to the reported incident.Per our procedure the remainder of the order was 100% inspected.A review of complaint history revealed no prior complaints for the listed lots (10fm03033, 08lt25649, and 09em09395), and one prior complaint for the listed lot (10fm16796).A review of the sterilization records revealed the liner, shell, and oxinium femoral head were sterilized according to sterilization release documentation from quality control.A review of the sterilization records for the head screw (08lt25649) revealed deviations that were previously evaluated by our internal capa group in 2011.This issue was reviewed and rated as not critical.If the devices or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.
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