The patient shoulder was revised to address pain, possible aseptic loosening.Both, a cemented non-porous humeral stem and glenoid component were found to not have been cemented in place.No surgical delay.Doi: (b)(6) 2008, dor: (b)(6) 2021; left shoulder.
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
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