Model Number N/A |
Device Problem
Defective Component (2292)
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Patient Problem
No Code Available (3191)
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Event Date 09/11/2014 |
Event Type
Injury
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Event Description
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It was reported a patient underwent a left comprehensive reverse shoulder arthroplasty on (b)(6) 2014.Subsequently the patient was revised on (b)(6) 2014 due to dislocation.The tray, glenosphere, humeral bearing and baseplate were removed and replaced.A further revision procedure has been indicated due to dislocation; however, no revision procedure has been reported to date.
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly related to the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity may also contribute to these conditions." this report is number 2 of 4 mdrs filed for the same event (reference 1825034-2014-08316 / 08319).
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.
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Event Description
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It was reported a patient underwent a left comprehensive reverse shoulder arthroplasty on (b)(6) 2014.Subsequently the patient was revised on (b)(6) 2014 due to dislocation.The tray, glenosphere, humeral bearing and baseplate were removed and replaced.Additional information received reports the patient underwent a subsequent revision procedure on (b)(6) 2014 due to dislocation.The glenosphere was removed and replaced with a custom product.
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Search Alerts/Recalls
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