Catalog Number UNK HIP FEMORAL STEM |
Device Problems
Corroded (1131); Naturally Worn (2988)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Discomfort (2330); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671)
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Event Date 11/27/2015 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).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 severe pain, discomfort, inflammation and friction and wear between the cobalt-chromium metal head and cobalt-chromium metal liner causing large amounts of toxic particles to be released into patient's blood, tissue and bone surrounding the implant.It was also reported, upon removal of the implant there was 30 cc's of blackish fluid aspirated.Doi: (b)(6) 2007: dor: (b)(6) 2015 (right hip).
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Manufacturer Narrative
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(b)(4).Investigation summary: no device associated with this report was received for examination.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).
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Event Description
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After review of medical records, patient was revised to address osteolysis secondary to metal on metal hip replacement.Revision notes stated that the head was removed with evidence of corrosion on the trunnion, removed all evidence of pseudotumor.Added patient's dob, ht, wt and medical history.
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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.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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