Catalog Number UNK HIP FEMORAL HEAD METAL |
Device Problem
Naturally Worn (2988)
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Patient Problems
Adhesion(s) (1695); Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Distress (2329); Osteolysis (2377); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
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Event Date 11/07/2022 |
Event Type
Injury
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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.The device catalog number is unknown; therefore, udi is unavailable.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.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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Mom pinnacle litigation record received.Patient alleges heavy metal poisoning from the toxic heavy metal released, pain, injury to muscle and tissue, suffered additional scar tissue formation and will have replacements with decreased longevity, metallosis, metal wear, metal poisoning, loss of enjoyment of life, limitation of daily activities, emotional trauma, and distress.Doi: (b)(6) 2008 - dor: (b)(6) 2022 (right 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.H6: metal related pathology (e1618) is being utilized to capture metal poisoning & blood heavy metal increased.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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Medical records received.Medical records report revision l tha with allograft and bone grafting - there was a large area of osteolysis about the femoral component.They debrided the osteolytic lesion right in the femur.They debride the soft tissues around the acetabulum.Mechanical loosening of internal right hip prosthetic joint, presents today for similar revision on the right and bone grafting of femoral cyst.Tissue was then curetted out the proximal femoral cyst sent to pathology.
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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: added: a2, b7 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: a1.
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Search Alerts/Recalls
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