DEPUY ORTHOPAEDICS, INC. 1818910 SROM*STM ST,30+4L NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM
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Catalog Number 563518 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Host-Tissue Reaction (1297); Cardiac Arrest (1762); Pain (1994); Discomfort (2330); Deformity/ Disfigurement (2360); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
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Event Date 03/28/2016 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Patient code: no code available ((b)(4)) used to capture the surgical intervention and emotional distress.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 alleged debilitating pain, discomfort, disfiguration, soreness, which negatively affecting her ability to perform activities of daily living, emotional distress, and friction and wear between cobalt-chromium metal head and chromium metal liner caused toxic cobalt-chromium.
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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, 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.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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In addition to what was previously alleged, ppf alleges metallosis.Pfs alleges bone deterioration, high levels of cobalt levels, heart attack 4 weeks after surgery, pain and limb asymmetry.After review of medical records, patient was revised on (b)(6) 2016 due to osteolysis from metal debris with possible secondary infection with obviously what appeared to be an infected, a prostalac cement was implanted.On (b)(6) 2016, patient was revised due removal prostalac.Added medical history, law firm, surgeon, patient height and weight.Updated unknown products and affected side.
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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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Search Alerts/Recalls
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