Catalog Number 3L92499 |
Device Problems
Corroded (1131); Degraded (1153); Appropriate Term/Code Not Available (3191)
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Patient Problem
Host-Tissue Reaction (1297)
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Event Date 04/10/2017 |
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.
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Event Description
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Litigation alleges patient suffers from a failed pinnacle hip.Update: 04/10/2017 sales rep has reported the patient was revised due to metallosis.Update: 30 nov 2017: pfs and medical records received.In addition to what was previously reported, pfs alleges , loss of mobility, difficulty in walking, loss of ability to perform daily activities, suffering, and mental anguish.After review of the medical records for the mdr reportability, patient was revised to address pain and elevated metal ions.Revision notes reported of serous fluid with large granulomatous pseudotumor and a significant amount of oxidation on the trunnion consistent with trunnionosis.Operative findings also reported a localized granulomatous adverse reaction to metallic debris.It was also stated that the cup was dislodged upon removing the liner.Mri reported of large proteinaceous fluid collection, extensive synovitis and alval.There is no laboratory result for the metal ions.Added cup to the complaint since it was removed and stem due to alleged high metal ions.Added complainant information.This complaint was updated on dec 13, 2017.
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Manufacturer Narrative
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(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, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Udi: (b)(4).
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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.No device(s) associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A complaint database search did find additional results but no related reports against the provided product code and lot number combination(s).Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.The reported event is considered one of the possible complications of joint replacement.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.- the device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was 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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Search Alerts/Recalls
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