Catalog Number UNK ATTUNE KNEE TIBIAL INSERT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Unspecified Infection (1930)
|
Event Date 01/15/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Clinical adverse event received for lower respiratory tract infection.Event is serious and is considered moderate.Event is not related to device and is definitely related to procedure.Date of implantation: unknown.Date of event (onset): (b)(6) 2022 (unknown knee).Treatment: unspecified injected and oral medication.
|
|
Manufacturer Narrative
|
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 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.A concomitant product was identified to be a competitor product used in conjunction with the previously reported adverse event.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
|
|
Search Alerts/Recalls
|