MAUDE Adverse Event Report: STRYKER IRELAND OSTEONICS ACCOLADE TMZF PLUS HIPSTEM; PROSTHESIS,HIP,SEMI-CONSTRAINED,UNCEMENTED,METAL/POLYMER,NON-POROUS,CALCIUM PHOS

Device Problem Corroded (1131)

Patient Problems Inflammation (1932); Pain (1994); Toxicity (2333)

Event Date 10/28/2019

Event Type  Injury  

Event Description

On (b)(6) 2008, bf received a right tha consisting of a stryker lfit, anatomic v40 cobalt-chrome femoral head size 36mm +5mm offset fitted on a accolade tmzf plus hip stem, paired with a trident psl acetabular shell fixed by two bone screws and a neutral trident x3 polyethylene liner.He is a skier and hiker and did not note much problems at the right artificial hip until about spring of 2019, when he developed new activity related right hip and groin pain especially with right hip flexion against resistance and right hip abduction against resistance.In 2015, he was seen by a rheumatologist for right hand weakness due to an undetermined condition that was deemed "rheumatoid-like".His cobalt levels were first checked on (b)(6) 2018, and his urine cobalt level was elevated at 14.6ppb and his whole blood cobalt level was elevated of 4.4 ppb.He began taking n-acetyl cysteine 600-1,800 mg/day for heavy metal chelation on (b)(6) 2018.His levels were rechecked on (b)(6) 2019, and they were 5.3 ppb in blood and 29.3ppb in urine.By this time, he was also noticing some hip symptoms.Metal suppression mri of the right hip showed two discrete foreign body granulomas in the anterior and posterior capsular area of the right hip.Hip abductor tendons look intact.His fdg pet brain scan is consistent with brain hypometabolism.By (b)(6) 2019, his blood cobalt was 4.6 ppb and his urine cobalt was 42ppb.Given the increasing symptoms at the hip, his fdg pet brain scan findings, and his rising cobalt levels, he elected to have the right hip revised on (b)(6) 2019.The trunnion and head bone showed gross corrosion.Posterior, anterior capsule and hip abductor tendons were inflamed.Fluid from right hip was aspirated and diluted 1:2 with local anesthetic, this was sent for cobalt analysis and was found to have a cobalt level of 470ppb.Fda safety report id# (b)(4).

• Brand Name: ACCOLADE TMZF PLUS HIPSTEM
• Type of Device: PROSTHESIS,HIP,SEMI-CONSTRAINED,UNCEMENTED,METAL/POLYMER,NON-POROUS,CALCIUM PHOS
• Manufacturer (Section D): STRYKER IRELAND OSTEONICS
• MDR Report Key: 9391811
• MDR Text Key: 168588383
• Report Number: MW5091353
• Device Sequence Number: 2
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/26/2019
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 98