MAUDE Adverse Event Report: STRYKER HOWMEDICA OSTEONICS CORP. TRIDENT X3 POLYETHYLENE INSERT 32MM ID E ; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Device Problems Corroded (1131); Appropriate Term/Code Not Available (3191)

Patient Problems Fatigue (1849); Memory Loss/Impairment (1958); Necrosis (1971); Injury (2348); Shaking/Tremors (2515); Sleep Dysfunction (2517)

Event Date 07/17/2015

Event Type  Injury  

Event Description

Pt id: (b)(6); on (b)(6) 2008, she underwent a right total hip arthroplasty for collapse of femoral head due to avascular necrosis.She was previously treated with an avascular necrosis device which was removed for implantation of the tha.The component of the tha were a howmedica restoration modular hip fluted distal stem 11mm x 127mm straight, howmedica lfit v40 cocr femoral head standard neck length 32mm (ref no 6260-9-132, lot no 24334504), trident x3 polyethylene insert 32mm id e, trident psl acetabular shell, restoration modular hip 19mm, osteonics cancellous bone screw, and the torx 6.5mm cancellous bone screw.On (b)(6) 2015, her urine cobalt level was 1.4 mcg/l.On (b)(6) 2015, serum / plasma cobalt level was 0.2 mcg/l.On (b)(6) 2018, her urine cobalt level was 1.4 mcg/l and serum /plasma cobalt level was 0.4 mcg/l.On (b)(6) 2019, her urine cobalt level was 2.5 mcg/l and the blood cobalt level was <1.0 mcg/l.On (b)(6) 2018, a metal-suppression mri of the right hip without contrast showed a significant fluid collection around the hip which tracks anteriorly along the iliopsoas tendon.Her hip abductors looked okay.Since hip replacement, she developed tremor of left hand which made her drop things, forgetfulness, sleep apnea, pain all over, fatigue, and progressive carpal tunnel syndrome in both hands.She had previously noted new anterolateral right hip symptoms and new food allergies.On (b)(6) 2019, the right hip was revised to a stryker 36 id e series neutral x3 socket liner, neck +4, delta ceramic option 36mm head.The stem was sound and was in about 20 degrees of anteversion, the trunnion and head bore showed gross corrosion debris.The poly was in very good condition but was revised to upsize the articulation to decrease the risk of prosthetic instability.There was moderate lysis about the proximal femoral component.The acetabular component was in about 45 degrees abduction and anteverted about 15 degrees, not loose, with no apparent lysis.There was severe synovitis with rice bodies mandating a complete synovectomy, posterior capsule was severely attenuated due to the expansile adverse reaction to metal debris requiring reconstruction.The anterior capsule was thickened and attenuated requiring debridement.The abduction tendons were 50% compromised requiring repair.Stability profile of the hip showed posterior instability due to anterior adverse reaction to metal debris.Anterior capsule attenuated with pseudotumor, posterior capsule was tenuous but repairable.Frozen section of right hip tissue notable for mild changes of metal-on-metal reaction with alvl score of 3 out of 10.Fda safety report id# (b)(4).

• Brand Name: TRIDENT X3 POLYETHYLENE INSERT 32MM ID E
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER HOWMEDICA OSTEONICS CORP. ; kalamazoo MI
• MDR Report Key: 9754007
• MDR Text Key: 181629574
• Report Number: MW5093293
• Device Sequence Number: 3
• Product Code: KWY
• 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: 02/21/2020
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• 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: 34 YR
• Patient Weight: 95