Catalog Number 121735500 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Arrest (1762); Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Tissue Damage (2104); Discomfort (2330); Injury (2348); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 12/01/2017 |
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.Litigation alleges that corrosion and friction wear had caused metal ion and particles to be released into the patient¿s blood and tissues and bone surrounding the implant resulting to injuries such as adverse local tissue reaction, pain, crunching or popping noises in the hips, standing and walking difficulties, hip fractures or dislocations, fatigue, tissue inflammation, necrosis, metallosis, limited mobility, and tissue and bone damage.The patient is also suffering from discomfort, emotional distress and other injuries caused by the failed hip implant.Doi: (b)(6) 2007; dor: (b)(6) 2017; left hip.Patient is bilateral, see (b)(4) for the right 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.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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Product complaint #: (b)(4).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. .
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Event Description
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Ppf alleges infection, heart attack and loose stem.
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Search Alerts/Recalls
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