Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.(b)(4).
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It was reported that the patient had a hip fracture on (b)(6) 2020, and a summit basic unipolar hemi arthroplasty.The patient returned to surgery today due to a painful hip and loosening of the stem at bone to implant interface and revision to a cemented summit total hip.Doi: (b)(6) 2020, dor: (b)(6) 2020, left hip.
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