Model Number 1506-10-005 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
|
Patient Problem
No Code Available (3191)
|
Event Date 06/19/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
The patient demonstrated ongoing valgus deformity and loosening.The patient was revised due to loosening of the tibial component at unknown interface.The femoral component was revised though not indicated to be loose.Doi: (b)(6) 2017 (patella and femoral component).Doi: (b)(6) 2017 (tibial tray, insert and bone cement).Dor: (b)(6) 2018 (left knee).
|
|
Manufacturer Narrative
|
This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
|
|
Search Alerts/Recalls
|