Model Number 5450-35-500 |
Device Problem
Loss of or Failure to Bond (1068)
|
Patient Problems
Fatigue (1849); Pain (1994); Ambulation Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
|
Event Date 06/02/2022 |
Event Type
Injury
|
Event Description
|
On (b)(6) 2022, patient has right knee pain, gait instability, joint swelling, limping, weakness, and knee giving away.She was treated with physical therapy, nsaids, aleve and dry needling.It was noted the patient had received lumbar epidural injections due to lumbar spondylolisthesis, disc degeneration, and idiopathic scollosis lumbar region.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).E3 initial reporter occupation: (b)(6).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Dmf# - (b)(4).Trade name (b)(6).Active ingredient(s) gentamicin sulphate.Dosage form - powder.Strength 1.0g active in our cements.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.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.
|
|
Search Alerts/Recalls
|
|