Model Number N/A |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Code Available (3191)
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Event Date 11/23/2015 |
Event Type
Injury
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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 or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 8 states, ¿dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions.¿ this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2016-00110 / 00111).
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Event Description
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It was reported that patient underwent right total hip arthroplasty on (b)(6) 2015.Subsequently, patient underwent non-surgical repositioning on (b)(6) 2015 due to luxation.No further information has been provided.
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Event Description
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There is no update to the prior event description provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.
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Search Alerts/Recalls
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