STRYKER ORTHOPAEDICS / HOWMEDICA OSTEONICS ACCOLADE TMZF PLUS HIP STEM #3; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
|
Back to Search Results |
|
Catalog Number 4021-0335 |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problem
Toxicity (2333)
|
Event Date 02/26/2008 |
Event Type
Injury
|
Event Description
|
I am reporting the stryker accolade tmzf plus hip stem.Since i have had it i have 7 dislocations and now my cobalt levels are rising because of the cobalt heads (stryker imp head v40 cocr 32 mm + 4 lfit and stryker lfit v40 head) my surgeon used for the two revisions on (b)(6) 2013 and (b)(6) 2017.After 4th dislocation hip surgeon revised my hip with stryker v40 cocr femoral metal head (cat 6260-9-232, lot 36628304) on (b)(6) 2013.My stem is stryker accolade tmzf plus #3.This dislocated (b)(6) 2014, (b)(6) 2017, and again on (b)(6) 2017.Surgeon did second revision and replaced with stryker lfit v40 femoral head (cat 6260-9-332, lot 51549603).Since then my cobalt serum levels have risen from 1.6 to 2.2 in 6 months.Surgeon called me friday and said he thinks we need to remove whole implant, stem and all.Fda safety report ids# (b)(4).
|
|
Search Alerts/Recalls
|
|
|