MAUDE Adverse Event Report: HOWMEDICA OSTEONICS CORP. STRYKER LFIT ANATOMIC V40 COCR HEAD; PROSTHESIS, HIP, SEMI-CONSTRIANED, METAL/POLYMER, CEMENTED

Model Number 6260-9136

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Apnea (1720); Fatigue (1849); Memory Loss/Impairment (1958); Toxicity (2333); Reaction (2414); Shaking/Tremors (2515)

Event Date 01/23/2018

Event Type  Injury  

Event Description

Patient: (b)(6); on (b)(6) 2007, he received a right total hip arthroplasty with stryker components, psl 60mm shell, single 35mm supplemental screw, 36 internal diameter trident x3 liner, 4.5 accolade tzmf plus stem, 36mm +0 lfit anatomic v40 cocr head (ref# 6260-9136, lot# w4emjd, exp date 06/2012).On (b)(6) 2018 his urine cobalt level was 29 mcg/l.On (b)(6) 2018, his urine cobalt level was 10 mcg/l, on (b)(6) 2018, his urine cobalt level was 27 mcg/l.On (b)(6) 2018, his blood cobalt level was 2.3 mcg/l and urine cobalt level 19.9 mcg/l.Around (b)(6) 2018, he started noticing problems with his balance, memory, mood, and energy level.He also developed a fine rest tremor of his hands.He had developed obstructive sleep apnea around 2014.He also noted some right hip symptoms with pool walking.Metal suppression mri of the right hip was made on (b)(6) 2018 showed a significant lateral pseudotumor starting to encroach upon the hip abductor tendons.This appeared to be solid lesion without much fluid in it.Fluid images suggested he does have some fluid in the joint although not a lot.At this point, his hip abductor tendons still appeared to be intact.Neuro q analysis of his fdg pet brain scan found 77 of 240 regions with significant hypometabolism with a summed regional hypometabolism score of -218, involving areas associated with chronic toxic encephalopathy, on (b)(6) 2018, the right hip was revised.The cocr head was simply swapped for a delta option ceramic head size 36mm +0.The trunnion and the head bore showed marked external and internal corrosion.Posterior capsule was thickened and of poor quality due to adverse reaction to metal debris, anterior capsule was thickened and of poor quality due to adverse reaction to metal debris, abduction tendons attenuated with a pale fish flesh appearance consistent with adverse reaction to metal debris and required repair.The trochanteric bursa was not effused.The cobalt level of the right hip joint fluid was 190 mcg/l, but it was diluted by about 1:10.About 15 months post revision on (b)(6) 2019, his blood cobalt level was 0.6 mcg/l and urine cobalt was 1.4 mcg/l.Fda safety report id # (b)(4).Fda received date: 02/21/2020.

• Brand Name: STRYKER LFIT ANATOMIC V40 COCR HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRIANED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): HOWMEDICA OSTEONICS CORP.
• MDR Report Key: 9753536
• MDR Text Key: 181631608
• Report Number: MW5093279
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2012
• Device Model Number: 6260-9136
• Device Lot Number: W4EMJD
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 73 YR