Batch review performed on 07 september 2015: lot 147183: (b)(4) stems manufactured and released on 13 february 2015.Expiration date: 2019-12-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported issue.On (b)(6) 2015 the medical affairs director made the following comment: a stem of same size as the originally-planned one has been inserted and looks well positioned.Therefore, the patient had to bear no consequence from this event except a slightly increased operative time.There are no other clinically relevant aspects of this claim.On 10 september 2015 the r&d project manager analysed the returned implant: observing the femoral stem no particular sign can be noted, except under the collar: such a sign was probably caused during the removal phase.A dimensional a documental control is currently underway at our cq department.To date, it is not possible from the inspection of the implant determine the root cause of the event.On 11september 2015 a dimensional check was made in cq department: the implant is in compliance with the stem design.On the same date the r&d project manager added the following: the dimensional and documental analysis on the returned coated stem (metrological analysis of the cq department done by means of the transparent templates used to control the forges of the implant) showed the total conformity of the returned prosthesis.The root cause of the complaint cannot be determined.
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