On (b)(6) 2016 the (b)(6) performed a clinical evaluation and commented as follows: proximal loosening in a cementless tha 1.5 years old.Only an intra-operative fluoroscopy shot is available, hence no real analysis is possible.No apparent reason for this stem to get loose could be identified on the image or the report.The cause for this problem remains unknown to date.Batch review performed on 23 september 2016.Lot 147177: (b)(4) items manufactured and released on 21 january 2015.Expiration date: 2019-12-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
|