Model Number 56-3618 |
Device Problem
Fracture (1260)
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Patient Problems
Ossification (1428); Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); Joint Laxity (4526)
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Event Date 11/08/2014 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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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Unf and pinnacle non mom medical records received.Initial reported reason for revision are the following fractured prosthetic femoral stem, pain, discomfort, clicking sensation, heterotopic bone ossification, impingement, metallosis, awaiting for medical records review task findings.Once available this complaint will be updated accordingly.Doi: (b)(6) 2010; dor: (b)(6) 2014 ; 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 was performed for the finished device 563618, lot - 3175579 and no non-conformances / manufacturing irregularities were identified.
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Search Alerts/Recalls
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