Catalog Number UNK HIP FEMORAL STEM SUMMIT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Fatigue (1849); Bone Fracture(s) (1870); Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032); Weakness (2145); Distress (2329); Discomfort (2330); No Code Available (3191); Metal Related Pathology (4530)
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Event Date 04/04/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Initial reporter occupation: lawyer.
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Event Description
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After review of medical records the patient was revised to address fall resulting to periprosthetic femur fracture.Operative note reported capsule was found to be disrupted and large pseudocapsule was present.The fracture was identified and the fragments 30 delineated.Stem was added due to femur fracture, sleeve since patient had asr xl implanted and explanted.Doi: (b)(6) 2006; dor: (b)(6) 2018: left hip.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.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).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), was not possible because the required lot code was not provided.
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Event Description
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In addition to what previously alleged, pfs alleges discomforts, difficulty activities in daily living and metal ions.
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Search Alerts/Recalls
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