An article/literature was received entitled " stable glenoid component of reverse total shoulder arthroplasty at 2 years as measured with model-based radiostereometric analysis (rsa)".Literature article entitled "stable glenoid component of reverse total shoulder arthroplasty at 2 years as measured with model-based radiostereometric analysis (rsa)" written by alexander nilsskog fraser, berte bøe, tore fjalestad, jan erik madsen and stephan m röhrl.Published by acta orthopaedica published online/accepted by publisher 1 jul 2021 was reviewed.The article's purpose was to follow 20 patients and assess stability of the glenoid component in reverse tsa, using model-based rsa.The 20 patients received primary treatment with a reversed tsa using a delta xtend shoulder.Specific patient identifiers were not given in the article.X-ray and ct images can be found on pages 3 and 4 of the literature article.Depuy products with known adverse event(s): metaglene x 2, locking screw x 4, glenosphere, humeral cup, humeral epiphysis, humeral stem.Adverse events: migration of the metaglene with no indicated treatment.Humeral cup notching with no indicated treatment.Septic loosening with revision.
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays were reviewed, and evidence of shoulder metaglenes and shoulder screws migration was found.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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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