The patient was revised to address loosening of the unknown component at the bone to implant interface.It was also reported that the patient had their shoulder done sometime around 2005.The surgeon wasn't sure of the exact date.The glenosphere failed and ripped out of the patients glenoid.The glenosphere came out in one piece.They were unable to identify the metaglene used, or the screw sizes that were removed.The surgeon was able to use a zimmer biomet augmented glenosphere, but wanted to maintain the humeral component.The sales rep informed him that it was off label to mix components, but he decided it was best for the patient.After he inserted their glenosphere, a trial reduction was performed with a 9mm spacer and 9mm poly.The 9mm spacer was opened and implanted, then he decided on using a 6mm poly.The shoulder was reduced and found to be satisfactory.The closing process began.Doi: 2005.Dor: (b)(6) 2019.Right shoulder.
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Product complaint # (b)(4).Investigation summary = > the device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.
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