Model Number 1218-87-354 |
Device Problems
Naturally Worn (2988); Noise, Audible (3273)
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Patient Problems
Edema (1820); Muscular Rigidity (1968); Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(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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Pcf and medical records received.After review of medical records, no revision notes reported.Patient alleges chronic pain, stiffness, walking difficulty, swelling, difficulty in wearing shoes and socks, difficulty with stairs, painful antalgic gait, limp, arthralgias, joint swelling, and myalgias.Physical exam stated decreased strength, tenderness, bony tenderness, swelling, and crepitus.Laboratory results stated elevated metal ions.Doi: (b)(6) 2008; dor: none reported (left hip).Patient is bilateral.See (b)(4) for the right hip.
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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.H10 additional narrative: added: b5, d10 and h6 (patient) corrected: h6 (device).
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Event Description
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Litigation alleges that the corrosion and friction wear believed to have cause amounts of toxic cobalt-chromium metal debris to be release into the plaintiff tissues surrounding the implant.Plaintiff began experiencing pain and difficulty in and around his implant.Metal ions were found to be elevated.
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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.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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Search Alerts/Recalls
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