Patient presented in clinic with painful right shoulder surgeon had replaced in (b)(6) 2003 at (b)(6) hospital.Patient also exhibited loss of function in right shoulder so the doctor elected to perform a revision surgery on patient¿s right shoulder.Performed revision surgery on (b)(6) 2019 at (b)(6) hospital.Surgeon removed the glenoid, humeral stem, and humeral head with instrumentation.He then elected to implant a reverse shoulder prosthesis using competitive systems.
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: 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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