Catalog Number UNK HIP ACETABULAR LINER METAL |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Joint Dislocation (2374); Swelling/ Edema (4577)
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Event Date 12/21/2016 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.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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Pfs and medical records received.Pds alleges pain and recurrent dislocation.After review of medical records, the patient was revised or recurrent dislocation.Operative notes reported that there was a lot of fluid that looked purulent, was most probably reactive from copious white cells due to metallosis.Doi: (b)(6) 2011; dor: (b)(6) 2016 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: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.
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Search Alerts/Recalls
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