Catalog Number UNK-HIP |
Device Problems
Corroded (1131); Osseointegration Problem (3003); Appropriate Term/Code Not Available (3191)
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Patient Problems
Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); Inadequate Osseointegration (2646)
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Event Date 10/17/2017 |
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.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.
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Event Description
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Oct 17, 2017: litigation record received.Litigation alleges corrosion and friction wear causing toxic cobalt-chromium metal debris, pain, limited mobility, discomfort, and elevated metal ions.There is no report of revision at this time.
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Manufacturer Narrative
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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.Depuy considers the investigation closed at this time.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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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.Device history lot : null.Device history batch : null.Device history review : null.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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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.H10 additional narrative: udi: (b)(4).Added: a2(dob), b5, d7, h4, h6(patient, device).
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Event Description
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Ppf alleges loosening of stem and metallosis.Added regstat codes, dor, surgeon, dob, law firm, product, lot number, manufacture and expiration dates (head and liner).
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Search Alerts/Recalls
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