Model Number 1365-51-000 |
Device Problem
Naturally Worn (2988)
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Patient Problems
Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/31/2020 |
Event Type
malfunction
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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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Pinnacle medical records.After review of medical records patient was revised to addressed pain, discomfort, injury, elevated cobalt and chromium levels, decreased range of motion.Clinic visits reported of leg length discrepancy, stiffness and wear debris.Patient is scheduled for left revision and underwent therapy.Doi: (b)(6) 2008, dor: scheduled left hip.(b)(4) right hip 1st revision.(b)(4) right hip 2nd revision.
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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: per wi-3430 it has been determined that should related reports be identified a dhr review is not required.
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Search Alerts/Recalls
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