Catalog Number UNK ATTUNE KNEE TIBIAL INSERT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930); Post Operative Wound Infection (2446); No Code Available (3191)
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Event Date 11/03/2019 |
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.(b)(4).
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Event Description
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The literature article entitled, "early experience with the attune total knee replacement system" written by stefano giaretta, mattia berti, gian mario micheloni, alberto ceccato, francesco marangoni, and alberto momoli published by acta bioment 2019 vol.90, supplement 12: 98-103 accepted by publisher on 3 november 2019 was reviewed.The article's purpose was to evaluate the short-term clinical and radiological results and survival using the attune total knee replacement system.Data was compiled from 192 tkas (185 patients) performed between january 2014 and january 2018.Cement manufacturer was non-depuy and patella resurfacing was not performed.Depuy products: attune total knee system primary the article provides radiographic imaging in figure 1a and 1b with narrative description "radiolucent lines." adverse events: tibial plate loosening (treated by revision and findings loose at implant-cement interface) infection (treated by two stage revision) patellar tendon lesion sonographically detected (treated with 20 days of immobilization in an extended brace followed by progressive rehab to complete functional restoration) superficial wound infection (treated by antibiotics) adhesions (treated by manipulation under anesthesia and/or arthroscopic lysis).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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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Search Alerts/Recalls
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