MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS / HOWMEDICA OSTEONICS ACCOLADE TMZF PLUS HIP STEM #3; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

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).

• Brand Name: ACCOLADE TMZF PLUS HIP STEM #3
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS / HOWMEDICA OSTEONICS
• MDR Report Key: 9146869
• MDR Text Key: 161357960
• Report Number: MW5090176
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/29/2019
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 4021-0335
• Device Lot Number: 9181004R
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 65 YR
• Patient Weight: 79