Catalog Number UNK HIP FEMORAL STEM |
Device Problems
Corroded (1131); Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Edema (1820); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Discomfort (2330); Toxicity (2333); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
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Event Date 10/07/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.(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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Pinnacle mom litigation record received.Litigation alleges friction and wear between cobalt and chromium metal head and liner caused large amount of metal ions and particles into blood, tissue and bone resulting to pain, discomfort and inflammation.Doi: (b)(6) 2008.Dor: not reported; right hip.
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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.H10 additional narrative: product complaint #(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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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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.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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Event Description
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Pfs, ppf and medical records received.In addition to what were previously alleged, ppf alleges metal wear, metallosis, and elevated metal ions.Pfs alleges metal toxicity, pain in hip joint with limited mobility.Patient reported bilateral hip pain.Right hip pain was persistent in the setting of a metal on metal articulation with elevated serum metal ion levels.After review of medical records, the patient was revised to address revision right total hip arthroplasty.Operative notes stated that there was an egress of clear fluid upon entering the joint.There was corrosion at the head trunnion junction, corrosion at the metal insert acetabular junction, acetabular component malposition with excessive vertical opening and anteversion.One bone screw was removed because the head of it sheared.Loss minimal bone anteriorly was noted.The trunnion was cleaned of any metallosis or debris.
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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. h6 patient code: no code available (3191) used to capture blood heavy metal increased and surgical intervention.
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Search Alerts/Recalls
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