Catalog Number 4CHL636 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Unspecified Infection (1930); Septic Shock (2068); Joint Dislocation (2374); Not Applicable (3189)
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Event Date 04/14/2018 |
Event Type
Injury
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Manufacturer Narrative
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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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Primary surgery was performed on (b)(6) 2005 for a glenohumeral arthrosis.Then the patient has been hospitalized on the (b)(6) 2018 with a septic shock.On the (b)(6) 2018 a removal surgery was performed.The stem appeared to be dislocated and with biofilm inside of the medullary canal.The glenosphere appeared to be dislocated as well and it presented infected material organized as a biofilm.
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Corrective action was not indicated.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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