Batch review performed on 04-mar-2022: lot 1903421: (b)(4) items manufactured and released on 29-jul-2019.Expiration date: 2024-07-15.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been already sold without other similar reported events.Additional implant involved: liner: mectacer 01.29.413 ceramic liner ø 36 / e (not registered in usa) lot.1903875: batch review performed on 04-mar-2022: lot 1903875: (b)(4) items manufactured and released on 26-jul-2019.Expiration date: 2024-07-14.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.Additional implant involved: stem: quadra-h 01.12.033 cementless, ha coated lat stem size 3 (k082792) lot.187837: batch review performed on 04-mar-2022: lot 187837: (b)(4) items manufactured and released on 06-feb-2019.Expiration date: 2024-01-07.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been already sold without other similar reported events.Additional implant involved: ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot.1902999: batch review performed on 04-mar-2022: lot 1902999: (b)(4) items manufactured and released on 12-jul-2019.Expiration date: 2024-06-29.No anomalies were found related to the problem.To date, all items of the same lot have been already sold without other similar reported events.Clinical evaluation performed by medical affairs department: late infection in cementless tha, 2 years after primary operation in a (b)(6) year old patient.Patient reported pain and instability in the articulation.Radiographic images provided, show cyst formation in the lateral dyaphisis which may be caused by the infection.All implants were removed and a spacer was inserted.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.
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Revision surgery was performed due to cyst formation and loosening of the femoral component, secondary to infection.The first stage revision was completed almost 2 years and 4 months after primary, all components were removed and the cement spacer was inserted.Stage two is to be completed at a later stage.
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