Model Number 1217-30-500 |
Device Problems
Loss of Osseointegration (2408); Osseointegration Problem (3003)
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Patient Problems
Edema (1820); Pain (1994); Swelling (2091); Discomfort (2330); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 10/19/2010 |
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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Patient was revised failed right total hip with severe pain.Operative note reported a small amount of clear yellow fluid was encountered.The cup was grossly loose and was malpositioned.Doi: (b)(6) 2008.Dor: (b)(6) 2010, (right hip).
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Manufacturer Narrative
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Product complaint # (b)(4).
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Event Description
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Pfs alleges swelling, lack of mobility, emotional distress and popping/clicking.
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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.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.No code available is used to capture emotional distress, medical device removal and surgical intervention.
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Search Alerts/Recalls
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