Model Number 1516-40-410 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/19/2019 |
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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On (b)(6) 2019, the patient underwent a second left knee revision to address pain.The surgeon noted the removal of scar tissue.The tibial insert, tibial tray, and femoral component were revised.The patellar component was retained.The surgeon noted minimal bone loss with removal of the femoral component.The patient was revised with depuy products.There were no indicated intra-operative complications.Doi: (b)(6) 2018 insert; doi: (b)(6) 2017 femoral, tibial tray; dor: (b)(6) 2019; left knee.
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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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