Model Number 1504-10-207 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Edema (1820); Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
|
Event Date 12/05/2017 |
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
|
Attune claim letter received.Claim letter alleges pain, limited mobility, swelling, and the cement had separated from the tibial plate following the first surgery which resulted in a destabilization of the right knee.Cement manufacturer is unknown.Doi: (b)(6) 2017; dor: (b)(6) 2017; right knee.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthese considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
|
|
Search Alerts/Recalls
|