Model Number 1570-11-180 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problems
Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Injury (2348); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 03/28/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.(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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Pinnacle litigation records received alleging pain, instability, injury and partial or complete loss of mobility.Doi: (b)(6) 2009; dor: not indicated (left hip).
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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.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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