Model Number 1518-10-038 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Muscular Rigidity (1968); Loss of Range of Motion (2032)
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Event Date 05/03/2021 |
Event Type
Injury
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Manufacturer Narrative
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(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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Revision of an attune tkr.All components were removed.Male right side no other co-morbidities stated reason for revision as stated on the joint registry form were: loosening femoral component.Loosening tibial component.Stiffness/arthrofibrosis (patient couldn't flex beyond about 75-80 degrees.Could get over 100/110 degrees of flexion after.Primary surgery was done in 2018 at (b)(6) by (b)(6).Depuy cmwll cement was used.The patient then had a knee aspiration in 2020.I don't know any other details about that.The operation was performed as two stages in one.All implants and cement was removed and then site was thoroughly cleaned.Tissue samples were taken to be sent away to test for any signs of infection.The patient was then draped again and the surgical team re-scrubbed.They were essentially treated as two separate operations.When surgeon began to remove the components it appeared they were actually well fixed.Implants had good cement fixation to them and into the bone.Attune revision components were implanted.
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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.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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Event Description
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Additional information received indicated that the surgeon confirmed that there was no infection found.
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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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