Pcf and medical records received.After review of medical records patient was revised to addressed pain, discomfort, walking difficulty, metallosis, bursitis, instability, debris, pseudotumor, and osteolysis.Doi: (b)(6) 2008; dor: (b)(6) 2019; left hip.
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: per (b)(4), it has been determined that should related reports be identified a dhr review is not required.
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