Model Number 1570-03-080 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Pocket Erosion (2013); Loss of Range of Motion (2032); Distress (2329); Osteolysis (2377); Ambulation Difficulties (2544); Fibrosis (3167); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/18/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.Follow-up is being conducted to obtain legal contact information.If/when the contact information is received, a supplemental med watch report will be submitted.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 unf and medical record received.After review of the medical records the patient was revised due to symptomatic metallosis, pseudotumor, alval, elevated metal ions, crp and sedimentation rate resulting to pain, bone necrosis of the proximal femur, large lytic lesion of the ischium, limp and leg length difference.Operative note reported pseudotumor fluid collection approx.15 cc of red serosanguinous fluid.There is significant pseudo-capsular expansion and grade tinted stained tissue consistent with metal debris and damage.Cup looks vertical and anteverted related to spinal pelvic imbalance.Compromise of the abductors by the necrosis of the trochanter from the metallosis damage.Pathology report component had thick fibrosis and synovial lining eroded.Moderate grade for alval.Lab result for chromium and cobalt shows above 7 ppb.Doi: 2009: dor: (b)(6) 2019; left 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.Device history lot : a device history record (mre) review, was not possible because the required lot code was not provided.
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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 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: e1, g2.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).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.Update (b)(6) 2021.Update (b)(6) 2021, received did not have any additional details to be added in investigation.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a device history record (mre) review, was not possible because the required lot code was not provided.H10 additional narrative: added: b5 and h6 (clinical codes).H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the bone injury and metal poisoning.
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Event Description
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Pinnacle litigation records was received.Litigation alleged that the patient suffered toxic heavy metal poisoning, tissue, muscle, and bone destruction.In addition to what were reported previously.Litigation alleges patient suffered heavy metal poisoning from toxic heavy metals resulting in injury, limited mobility, emotional trauma and distress.Doi: (b)(6) 2009; dor: (b)(6) 2019; left 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.Device history lot : a device history record (mre) review, was not possible because the required lot code was not valid.
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Search Alerts/Recalls
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