The patient was revised to address fracture after tha and loosening of summit stem at the bone to implant interface.We were not told how she fractured her hip, her stem had subsided due to the fracture and doctor decided to remove the stem and replace with a longer 8" solution stem.He removed the summit stem and prepped for and replaced with the solution stem.The stem was stable with the same size head so he re- implanted.Doi: (b)(6) 2019.Dor: (b)(6) 2020, right hip.
|
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|