Model Number 130760142 |
Device Problems
Fracture (1260); Device Dislodged or Dislocated (2923); Noise, Audible (3273)
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Patient Problem
No Code Available (3191)
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Event Date 01/14/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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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Event Description
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It was reported that the patient underwent a delta xtend reverse performed by the surgeon in (b)(6) of last year.Initially, the patient did well with the prothesis.Sometime late in 2019 however, the patient notice a large "creaking" and "grinding" sound when he moved his shoulder.This sound was confirmed in clinic by the surgeon and by(b)(6).All parties agreed that an exploratory surgery needed to take place.A scope was initially performed day of surgery on (b)(6) 2020 and it was noted very quickly that the glenosphere component has disassociated from the metaglene baseplate.The shoulder was then opened surgically and indeed the glenosphere was disassociated from the baseplate and the insertion peg on the backside of the glenosphere implant was broken in two.Doi: (b)(6) 2019; dor: (b)(6) 2020; left shoulder.
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Manufacturer Narrative
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Product complaint #(b)(4).Investigation summary = > examination of the returned device confirms the reported event.This analysis does not highlight any supplier defect and the need of corrective actions is not indicated.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, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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