Catalog Number UNK HIP FEMORAL HEAD METAL |
Device Problem
Naturally Worn (2988)
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Patient Problems
Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Distress (2329); Metal Related Pathology (4530)
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Event Date 09/30/2020 |
Event Type
Injury
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Event Description
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Pinnacle mom litigation record received.Litigation alleges heavy metal poisoning from toxic metals release by the pinnacle system resulting to metallosis, scar tissue formation, hip pain, metal wear and limited activities of daily living.Plaintiff also suffer from emotional trauma and distress seeking compensation for all the damages.Doi: (b)(6) 2007, dor: (b)(6) 2020, left hip.
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.(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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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.H6: metal related pathology (e1618) is being utilized to capture blood heavy metal increased & metal poisoning.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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After review of medical records, medical reported that the patient was revised on (b)(6) 2020 due to failed left total hip arthroplasty secondary to metallosis and adverse local tissue reaction.Preoperative reported patient had progressive worsening lateral-sided pain.Cobalt and chromium levels were elevated at 16 and 4.7 respectively.
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Event Description
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Medical records report failed left total hip arthroplasty secondary to metallosis and adverse local tissue reaction.There was noted to be black metal staining debris on the trunnion and inner surface or the head.In between the liner and the shell, there was noted to be a thin layer of dark yellowish cheesy appearing debris.Black metal staining debris was mentioned on the trunion and inner surface of the head.
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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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