Asr revision to take place(b)(6) 2014.Asr xl acetabular system - right.Reason(s) for revision: raised cobalt levels.Effusion of hip joint.Correct lot no for stem - c51hw1000.Patient name and claim no - (b)(6).Update rec'd 29 jan 2014 - revision date changed to (b)(6) 2014.Update -manufacturing dates, received confirmation that revision has taken place.Taken from (b)(6) dated (b)(6) 2014.Update nov 17, 2017: email notification from (b)(6) received.There is no new information.This complaint was updated on (b)(6) 2017.
|
Asr revision to take place (b)(6) 2014 asr xl acetabular system - right reason(s) for revision: raised cobalt levels.Effusion of hip joint correct lot no for stem - c51hw1000 patient name and claim no - (b)(6) update rec'd 29 jan 2014 - revision date changed to (b)(6) 2014 - attached claimsuite update -manufacturing dates, received confirmation that revision has taken place.Taken from (b)(6) spreadsheet dated 15th april 2014 update nov 17, 2017: email notification from (b)(6) received.There is no new information.This complaint was updated on nov 21, 2017.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|