Catalog Number 999890249 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cyst(s) (1800); Dyspnea (1816); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Necrosis (1971); Pain (1994); Anxiety (2328); Distress (2329); Deformity/ Disfigurement (2360); Fibrosis (3167); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559); Physical Asymmetry (4573); Swelling/ Edema (4577)
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Event Date 06/08/2022 |
Event Type
Injury
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Event Description
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Litigation complaint received ad 7 jul 2022.Claim letter alleges breathing difficulties, very high levels of metal toxicity.Patient was revised was due to metallosis, a tumor, cysts and necrotizing tissue.Doi: 18 years ago.Dor: (b)(6) 2022.Unk hip.
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.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).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 manufacturing record evaluation (mre), 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).Investigation summary update 29 july 2022: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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 device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.H10 additional narrative:.
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Event Description
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Surgical pathology final report received.On (b)(6) 2022 a result was dense fibrosis with collagen necrosis, fibrin deposition, and abundant histiocytes with grayish brown pigment consistent with metallosis, rare acute inflammatory cells.Affected side is 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.H10 additional narrative: added: e1 (law firm), e3 (initial reporter occupation: lawyer), d6a, h6 ((health effect-clinical code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: b5, d6b.
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Event Description
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The patient was alleged to experience pain, increased metal levels in blood including cobalt and chromium, injuries, emotional distress, and disfigurement.Doi: (b)(6) 2007 dor: (b)(6) 2022 right hip.
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Manufacturer Narrative
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Product complaint # (b)(6).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: device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.H10 additional narrative: added: a2 (age, dob), a4, b5, b6, b7, d10, h6 corrected: b3.
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Event Description
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Medical records were received and stated the following: pfs alleges injuries on tendons, ligaments, tissues, bones within right hip.Plaintiff suffered extreme pain, trochanteric fractured, elevated metal ions, pseudotumor, metallosis and anxiety.After review of the medical records the patient was revised to address hip pain, elevated metal ions, fractured greater trochanter, pseudotumor, metallosis, trunnionosis and vertical cup.Operative note reported metallosis in the posterior capsule.There was fluid in the hip, trunnionosis in the femoral head.Pseudotumor appear to track up the iliopsoas.There was leg length discrepancy.Doi: (b)(6) 2007;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 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: h6 (clinical codes), h7, h9 h6 clinical code: - swelling/ edema (e2338) is used to capture swelling and edema.- unspecified tissue injury (e2015) is used to capture soft tissue injury and bone 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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Search Alerts/Recalls
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