MAUDE Adverse Event Report: STRYKER IRELAND OSTEONICS STRYKER LFIT ANATOMIC V40 COCR HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Encephalopathy (1833); Fatigue (1849); Inflammation (1932); Pain (1994); Rash (2033); Toxicity (2333); Shaking/Tremors (2515); Sleep Dysfunction (2517)

Event Date 05/11/2015

Event Type  Injury  

Event Description

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).

• Brand Name: STRYKER LFIT ANATOMIC V40 COCR HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): STRYKER IRELAND OSTEONICS ; kalamazoo MI
• MDR Report Key: 9753775
• MDR Text Key: 181719980
• Report Number: MW5093286
• Device Sequence Number: 1
• Product Code: LWJ
• 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
• 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
• 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: 69 YR
• Patient Weight: 90