Catalog Number 999890253 |
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); Pain (1994); Scar Tissue (2060); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/24/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).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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Litigation complaint received ad 2 may 2022.Pfs and medical records received.Pfs alleges pain and suffering.After review of medical records, it was reported that patient complaints of pain and elevated metal ions, then was revised for failed metal on metal tha.Operative notes reported that there was a pseudocapsule encountered consistent with patient metal on metal reaction.There was yellowing-brownish fluid that were removed.There was a pseudotumor filled with yellow spongy material that was evacuated.A great deal of time was spent removing the scar tissue to improved our exposure as well as removing the scar tissue to improve exposure.There was a layer of black material inferior to the taper consistent with corrosive material.Doi: (b)(6) 2008; dor: (b)(6) 2020 right 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.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.
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Search Alerts/Recalls
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