Model Number 1570-12-120 |
Device Problem
Degraded (1153)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Distress (2329); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
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Event Date 11/25/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).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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Medical records received.After review of medical records patient was revised to addressed mechanical failure left internal prosthesis, failed metal on metal hip replacement.Operatives notes elevated cobalt and chromium level, extensive metallosis, minimal bone loss and minimal trunnionosis on the femoral neck.There was damage to the acetabular locking mechanism and decision was made to remove the cup.Doi: (b)(6) 2009 dor: (b)(6) 2019 left hip.
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Manufacturer Narrative
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Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Corrected: h6 (patient) from device revision or replacement to surgical intervention.No code available (3191) is used to capture soft tissue injury.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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Update ad 14 sep 2020.Litigation records received.Litigation records alleges, corrosion, friction wear, toxic cobalt chromium metal debris, pain, difficulty in and around her implant, extensive tissue damage and metallosis as well as suffering, metal anguish, distress, disfigurement and physical impairment.
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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.
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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.
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Search Alerts/Recalls
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