Catalog Number 121887462 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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Event Date 04/20/2023 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint #(b)(4).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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Metal on metal hip medical records received.After review of the medical records the patient was revised to address infected right tha with metallosis and pseudotumor resulting to hip pain and elevated metal ions.Mri confirmed pseudotumor.Slight elevated cell counts and sed rate.Aspiration confirmed infection.Operative note reported scarred external rotator and purulent appearing fluid obvious brownish pseudotumor.There was corrosion on the trunnion however, stem was well fixed.There was 2 screws 1 easily remove and the other one is very difficult to remove.There was acetabular membrane in the liner and some small cavitary defects.Doi: (b)(6) 2007; dor: (b)(6) 2023; 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.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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