Catalog Number 999890251 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
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Patient Problems
Fatigue (1849); Foreign Body Reaction (1868); Muscular Rigidity (1968); Pain (1994); Anxiety (2328); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Osteolysis (2377); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559)
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Event Date 08/18/2022 |
Event Type
Injury
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Event Description
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Litigation complaint received, patient underwent a revision due to severe pain and discomfort, increased metal levels in blood including cobalt and chromium; permanent injuries, emotional distress, disability, disfigurement; economic damages.Doi: (b)(6) 2008, dor: (b)(6) 2022, right hip.
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Manufacturer Narrative
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Product complaint # (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.E3 initial reporter occupation: lawyer.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.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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Pfs records received.Patient sustained physical injuries in his tendons, ligaments, tissues and bones within his right hip.Patient suffered from pressure in his right hip and intermittent discomfort.Suffered elevated cobalt and chromium levels as well as trunnionosis.Surgeon informed the patient to have revision.During revision, surgeon found metallosis throughout the hip and also osteolysis.Patient experience some persistent weakness and stiffness and clicks when walking.Patient have anxiety about the damage that the asr caused and future damage that the high ion levels and metal in his bloodstream.
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Manufacturer Narrative
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Product complaint # (b)(4).D4.Gtin: product was marked for gudid exclusion.Unique identifier( udi) : udi/gtin information is not applicable.Product is no longer marketed.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: (lot, catalog, expiry date), (pma/ 510(k)), health effect - clinical code.H6: unspecified tissue injury (e2015) is being utilized to capture soft tissue injury & bone injury.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: (concomitant), medical device problem code.
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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 : device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.
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Search Alerts/Recalls
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