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Catalog Number 101214040 |
Device Problems
Corroded (1131); Appropriate Term/Code Not Available (3191)
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Patient Problems
Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Muscular Rigidity (1968); Pain (1994); Discomfort (2330); Numbness (2415); Ambulation Difficulties (2544)
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Event Date 05/23/2016 |
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 the patient was implanted with a metal-on-metal pinnacle device and underwent a painful and risky revision surgery.Update jun 01, 2017: legal medical records received.In addition to what was previously alleged, pfs alleges pain, discomfort, numbness, feeling of slipping of the device in and out of the socket, stiffness, affecting mobility and daily activities.After review of the medical records for mdr reportability, it was stated that the patient was revised to address pain, stiffness, and dysfunction.Op notes indicate there is a slight elevation of her cobalt-chromium levels, as well as an abnormal fluid collection on mri consistent with pseudotumor.Revision notes stated that there was a brownish black fluid extracted consistent with an adverse response on metal-on-metal articulation, brown amorphous tissue consistent with an avascular lymphocytic reaction.It was also stated that the hip was noted to have excellent stability and significant corrosion was noted at the head and neck junction.It was also noted that the acetabular cup was initially in increased vertical orientation so a +4 neutral polyethylene liner was placed to accommodate the 36mm head.Stem was added due to the reported corrosion.There are no laboratory values for the reported elevated metal ions.Part and lot information were provided.This complaint was updated on: jun 09, 2017.
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Event Description
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Ppf alleges metal wear and metallosis.
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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.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.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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