Batch review performed on 19 sep 2019: lot 164501: 90 items manufactured and released on 28-oct-2016 expiration date: 13/10/2021.No anomalies found related to the problem.To date, 86 items of the same lot have been already sold without any other similar reported event clinical evaluation performed by medacta medical affairs director: revision surgery performed 2 years after cementless double-mobility total hip arthroplasty in a 66 year old woman.The patient was complaining about hip instability.Acetabular component looks slightly horizontal in the radiographic image provided and probably caused impingement between stem and cup.The reason of this position cannot be determined on the basis of a single pre-revision x-ray.Furthermore, it is not known if lumbar fusion devices were already in place at time of primary surgery, but this is a potentially seriously contributing factor because the pelvis position has probably been altered.The reason of this event cannot be determined.Preliminary investigation performed by medacta hip r&d project manager: from preliminary visual investigation it is not possible to determine any implant related failure root cause.
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