Model Number 1547-05-001 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Unspecified Infection (1930); Joint Disorder (2373); Joint Dislocation (2374); No Code Available (3191)
|
Event Date 03/26/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
(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
|
Removal of attune revision, patient required all implants removed due to instability and infection (no collateral ligaments) from revision pc-(b)(4), (b)(6) 2020 from a poly exchange due to instability.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
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. product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search did find other reported incident(s) against the provided product/lot combination(s) but they were all from the same patient and none were found to be related to a product defect.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|