Catalog Number 136562000 |
Device Problems
Material Disintegration (1177); Device Dislodged or Dislocated (2923); Insufficient Information (3190)
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Patient Problems
Unspecified Infection (1930); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Tissue Damage (2104); Discomfort (2330); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189)
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Event Date 08/11/2016 |
Event Type
Injury
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Manufacturer Narrative
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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.Litigation alleges extreme and severe pain, discomfort, localized joint swelling, inflammation and severe infection in his hip caused by metallosis.Patient also experienced loss of mobility, loss of range of motion, mental anguish and diminished enjoyment of life.Doi: (b)(6) 2007; dor: (b)(6) 2016; (left hip).
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Manufacturer Narrative
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Product complaint # = > pc-(b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.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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Manufacturer Narrative
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Udi: (b)(4).
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Manufacturer Narrative
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(b)(4).No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.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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Search Alerts/Recalls
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