Batch review performed on 20 july 2016.Lot 110555: (b)(4) items manufactured and released on 05 april 2011.Expiration date: 2016-02-29.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.On 22 july 2016 the medical affairs performed a clinical investigation and commented as follows: stem loosening in a tha on a lady of (b)(6) after 5 years.The stem appears to be radiographically loose in the lateral proximal region and also, to a lesser extent, in the medial area, therefore removal is necessary.No reason can be determined for this loosening.Aseptic loosening in cementless stems following tha is a known possible complication that idiopathically affects a small percentage of the operated joints; a clear cause cannot always be found.Not available.
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