Catalog Number 157011120 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
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Event Date 10/20/2015 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # : (b)(4).E3 initial reporter occupation: lawyer.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.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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Complaint description: patient was revised due to pain.Update rec'd 5/25/2016: litigation received.Litigation also alleges discomfort, metallosis, and elevated metal ions.The stem is being added to the complaint.A doi was provided.This complaint was updated on: (b)(6) 2016.Update ad (b)(6) 2018: com-(b)(4) has been re-opened under pc-(b)(4) due to the receipt of ppf and medical records.Ppf alleges of pseudotumor, fracture bone, abductor muscle repair, infection requiring iv antibiotic and loosening of stem.After review of medical records for the mdr reportability, patient was revised to address painful right hip metal-on-metal implant.Stem, head and cup was updated.Liner was added due to alleges infection.Date of revision in right hip was updated to (b)(6) 2015.Revision in left hip was captured under pc-(b)(4).
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Manufacturer Narrative
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Product complaint # (b)(4).This report is a duplicate of 1818910-2016-21158 and that all subsequent additional information will be reported under 1818910-2023-15738.
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Search Alerts/Recalls
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