Catalog Number UNK SHOULDER |
Device Problem
Disassembly (1168)
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Patient Problem
Pain (1994)
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Event Date 01/03/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (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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Der states that the patient complained of pain.The baseplate of the delta extend reverse radiographically appeared to be placed too far superior.It also appears that the glenosphere was not seated all the way.While in the shoulder it was evident that the ball was loose and spinning on the baseplate as though it had never been tightened enough for the morse taper to engage.The surgeon decided that the best thing for this patient was to put in anew eccentric 38 glenosphere and remove the original 38 standard that was loose.There was noted blackened tissue cause from the ball spinning around the base plate.He encourage the surgeon to remove the baseplate and put in a new one because of damage that may been created on the baseplate that might inhibit a good taper lock with the new ball.He understood my concerns but decided against changing the baseplate.We just did a glenosphere/poly swap.It was also reported that there was a bone/implant loosening interface.Doi: (b)(6) 2016; dor: (b)(6) 2018.Unknown shoulder.
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Manufacturer Narrative
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(b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.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. .
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Search Alerts/Recalls
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