Catalog Number UNK KNEE FEMORAL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Unspecified Infection (1930); Thrombosis/Thrombus (4440)
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Event Date 08/02/2022 |
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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Article entitled ¿application of enhanced recovery after surgery in knee arthroplasty for obese patients¿ written by lv meng, luo qi, zhou tianjian, wang hua, and lin bowen published in guangdong medical journal in october of 2017 was reviewed.The purpose of the study was to explore the application mode and clinical effect of enhanced recovery after surgery (eras) perioperative management strategy in tka in obese patients.76 patients were involved in the study.All patients were implanted with cemented pfc implants without their patella being resurfaced.Cement manufacturer is unknown.Adverse events: 5 cases had wound aseptic complications ¿ no indication of treatment.3 cases had postoperative infection - no indication of treatment.2 cases had postoperative deep venous thrombosis - no indication of treatment.1 case had wound aseptic complications and postoperative infection.
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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.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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Search Alerts/Recalls
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