STRYKER LFIT ANATOMIC V40 COCR HEAD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for STRYKER LFIT ANATOMIC V40 COCR HEAD manufactured by Stryker Ireland Osteonics.

Event Text Entries

[181719980] Pt id: (b)(6) on (b)(6) 2009, she received a right total hip arthroplasty using stryker uncemented components 54mm psl socket, 36 internal diameter x3 liner, +4 tzmf accolade stem, and 36mm +5 cocr head. On (b)(6) 2015, serum cobalt level was 4. 3 mcg/l and urine cobalt level was 13 mcg/l. On (b)(6) 2017, his urine cobalt level was 14. 0 mcg/l and a serum/plasma cobalt level was 4. 0 mcg/l. On (b)(6) 2017, whole blood cobalt level was 2. 6 mcg/l. On (b)(6) 2017, her whole blood cobalt level was 1. 9 mcg/l and urine cobalt level was 47 mcg/l. Since hip replacement, she has had onset of sleep apnea, fatigue, and fine rest tremor of the hands. On (b)(6) 2015, she reported problems with new symptoms of rash, fatigue, dyspnea on exertion, and activity related pain about the right prosthetic hip. On (b)(6) 2014, she had an echocardiogram notable for "probably normal diastolic dysfunction" and "mild concentric left ventricular hypertrophy. " with "increased (hyperdynamic) left ventricular ejection factor" ef of 78%. On (b)(6) 2017, she had an fdg pet brain scan with neuroq assessment showed an aggregate global score of hypometabolism of - 97. 34 with 8 abnormal clusters of 47, involving areas that are compatible with chronic toxic encephalopathy. Metal suppression mri of right hip done in (b)(6) of 2015 notable for a large trochanteric fluid collection measuring 3. 5 cm by 2 cm. Metal suppression mri of right hip done (b)(6) 2018 showed definitive fluid collection about the hip, most notably at the trochanteric bursa. There was some question of attrition of the posterior capsule. The hip abductor tendons look okay. On (b)(6) 2018, the right hip was revised to a stryker 36 id +6 lateralizing socket liner and a delta ceramic 36mm +4 head. The old stem was sound and was in about 20 degrees of anteversion, the trunnion and head bore showed gross corrosion. Posterior capsule was deficient inferiorly and involved in the adverse reaction to metal debris, anterior capsule was thicken and involved in the adverse reaction to metal debris, abduction tendons were involved at the trochanter, and trochanteric bursa was not effused. Intraoperative frozen section of right hip tissue showed chronic inflammation and metallosis. Cobalt level of the right hip joint fluid was 420 mcg/l and chromium level was 840 mcg/l. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093286
MDR Report Key9753775
Date Received2020-02-25
Date of Report2020-02-21
Date of Event2015-05-11
Date Added to Maude2020-02-26
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTRYKER LFIT ANATOMIC V40 COCR HEAD
Generic NamePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
Product CodeLWJ
Date Received2020-02-25
OperatorLAY USER/PATIENT
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER IRELAND OSTEONICS
Manufacturer AddressKALAMAZOO MI US


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2020-02-25

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