Model Number 1504-10-106 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Edema (1820); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Synovitis (2094); No Code Available (3191)
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Event Date 12/17/2018 |
Event Type
Injury
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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.(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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The patient was revised to address infection.All implants were taken out.
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Event Description
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Primary operative notes indicate the patient received a left primary attune to treat osteoarthritis.The patella was resurfaced and depuy cement x 2 was utilized.The procedure was completed without complications.Primary part/lot is provided on page 8.Revision operative notes indicate the patient received a total left knee revision to treat pain secondary to septic loosening.Upon entering the joint, the surgeon evacuated moderate bloody effusion and scar tissue and performed a synovectomy.Pathology reports identified acute and chronic inflammation, synovitis, elevated neutrophils, and reactive fibrosis consistent with foreign body reaction.The tibial tray was loosened at the cement to implant interface and easily removed.The femoral component was well-fixed but revised.The patella was retained.There was no reported product problem with the explanted tibial insert.The patient was revised with an antibiotic spacer.The procedure was completed without complications.
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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: a2 (dob, age), b5, b7, d4 (lot, expiry), d6, d11, h4, h6 (patient code).H6 patient code: no code available (3191) used to capture the device revision or replacement.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.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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