MAUDE Adverse Event Report: HOWMEDICIA OSTEONICS CORP. STRYKER V40 COCR HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 6260-9-236

Device Problems Corroded (1131); Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problems Memory Loss/Impairment (1958); Blurred Vision (2137); Visual Impairment (2138); Toxicity (2333); Joint Dislocation (2374); Reaction (2414); Ambulation Difficulties (2544)

Event Date 01/25/2016

Event Type  Injury  

Event Description

Patient: (b)(6).On (b)(6) 2008, he received a right total hip arthroplasty.Implants consisted of stryker lfit anatomic v40 femoral head size 36mm +5 offset v40 taper ref# 6260-9-236 lot# 90nmed exp 11/2012, howmedica osteonics accolade tmzf plus hip stem #5.5, stryker trident x3 polyethylene line 36mm alpha code h, and a trident acetabular psl shell.On (b)(6) 2016, blood cobalt level was 7.4 mcg/l and on (b)(6) 2016, urine cobalt level was 19.8 mcg/l.On (b)(6) 2016, his blood cobalt level was 6.8 mcg/l and urine cobalt level was 28.9 mcg/l.Metal suppression mri of the right hip showed evidence of adverse reaction to meatal debris.In the summer and fall of 2016, he started noticing problems with his balance, short term memory, and word-finding/conversational abilities.He was beginning to forget familiar words and names, and would often find himself working on something and then forget what he was working on.He also began developing fatigue, high frequency hearing loss, and rest tremor of this hands.He was no longer able to hear the bells during christmas symphony.He was starting to develop blurry and fuzzy vision.Fdg pet brain scan with neuro q analysis was notable for general and focal hypometabolism compatible with chronic toxic encephalopathy.On (b)(6) 2016, the right hip was revised.The cocr head and x3 liner were revised for stryker delta option ceramic 36mm +4 head and an eccentric 36mm id polyethylene liner.The trunnion and head bore showed abundant corrosion debris.Posterior capsule was thickened with the adverse reaction to metal debris and required debridement but was salvageable and repairable.There was extensive heterotopic ossification at the lesser trochanteric area that was resected with the saw and osteotomes.The anterior capsule was thickened.Fluid was aspirated from the right hip, and the cobalt level of this right hip joint fluid was 1,9000 mcg/l and chromium was 9,500 mcg/l.Due to significant residual soft tissue damage around the right hip, he had 2 posterior dislocations of his revised right hip s/p revision surgery.On (b)(6) 2016, patient dislocated the right hip while picking something up off the ground and his hip was reduced in the hospital.On (b)(6) 2016 patient dislocated the right hip again while wiping himself while hovering over a very low hotel toilet while on a trip in (b)(6) and the hip was reduced at (b)(6) hospital.Patient was anesthetized fore both reductions.One month after revision, he attended the same christmas symphony he always attended and was able to hear the bells again.His hearing generally improved.He was able to see clock faces again, which were beginning to appear blurry and fuzzy prior to his revision.By this time, (b)(6) 2016 his urine cobalt was 4.4 mcg/l and his blood cobalt level was 3.1 mcg/l.By (b)(6) 2018, his urine cobalt was 3.1mcg/l and his blood cobalt level was 1.1mcg/l.He has retained bilateral chrome cobalt knee implants and consequently his blood cobalt level continues remain above 1mcg/l.Fda safety report id # (b)(4).Fda received date: 02/21/2020.

• Brand Name: STRYKER V40 COCR HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): HOWMEDICIA OSTEONICS CORP.
• MDR Report Key: 9753485
• MDR Text Key: 181631512
• Report Number: MW5093278
• Device Sequence Number: 1
• Product Code: JDI
• 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

1 Device was Involved in the Event

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: Lay User/Patient
• Device Expiration Date: 11/01/2012
• Device Model Number: 6260-9-236
• Device Catalogue Number: 6260-9-236
• Device Lot Number: 90NMRD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 136