Only right side implants were involved (primary surgery bilateral), the invoice did not state which stem/head were implanted in right hip.On 21 october 2016 the initial reporter added that: i was not able to get the explants to return them, and i have asked the hospital but they do not have record of which specific lot number the implant was.On 04 november 2016 the medical affairs director performed a clinical evaluation and commented as follows: stem revision in a cementless tha after 5 years.Implants seem to be correctly positioned; only one projection is available so no estimation of correct sizing can be made from the images.Orientation, in the one projection available, appears to be correct.The contralateral hip, identical, seems to be well performing after the same period of time.The cause for this loosening cannot be identified with the information available.Batch review made on 08 november 2016 on both the lots of stems implanted (same code) in the same bilateral surgery: (b)(4).
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