On 18 august 2017 the medical affairs performed a clinical evaluation and commented as follows: partial revision on a cementless primary tha after 1,5 years.The quality of the available x-rays is extremely poor and no real assessment can be made.It appears that the stem is proximally debonded and radiographically loose.Some black shadows, both proximally and distally, are visible, but we cannot determine whether they are visual artefacts or signs of a specific situation.The root cause for this failure cannot be determined with the information at hand.Batch review performed on 22 august 2017.Lot 140016: (b)(4) items manufactured and released on 08 april 2014.Expiration date: 2019-02-28.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.
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On 13 september 2017 the r&d project manager performed a visual inspection of the retrieved items and commented as follows: the stem was analyzed.The ha coating was totally absorbed in the distal region while in metaphysial area was still present, indicating an unproper fixation in the proximal region that could have caused the pain in the patient.Fibrotic tissues was noticed in some macrostructures and a small groove was present under the taper, probably occurred during the revision.The ceramic ball head showed some signs on the rim, probably occurred during the extraction from the stem.From the received pieces it was not possible to determine the root cause of the event.
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