MAUDE Adverse Event Report: STRYKER ORTHOPEDICS STRYKER COCR HEAD FOR A V40 TAPER ; PROSTHESIS, HIP, SEMI-CONSTRAINED METAL/POLYMER, POROUS, UNCEMENTED

Device Problem Corroded (1131)

Patient Problems Apnea (1720); Cardiomyopathy (1764); Edema (1820); Inflammation (1932); Left Ventricular Hypertrophy (1949); Necrosis (1971); Pain (1994); Toxicity (2333)

Event Date 08/03/2016

Event Type  Injury  

Event Description

Pt id: (b)(6); on (b)(6) 2010, he received a right total hip arthroplasty.The implant consisted of stryker uncemented components, size 52 psl shell, x3 36 id polyethylene liner, accolade tzmf puls size 4.5 stem and 36mm+10 cocr head v40 taper.Around 2016, he started experiencing significant right hip pain especially with activity.In addition to the hip symptoms, he began experiencing new onset of sleep apnea, cardiomyopathy, and nonrefractive vision problems.Metal suppression mri of the right hip showed prominent fluid collection in the posterior right hip joint area with incomplete attachment of the gluteus medius to the greater trochanter with concomitant atrophy of the gluteus musculature of the right pelvis.Echocardiogram done on (b)(6) 2016 showed increased left ventricular cavity size, mild concentric left ventricular hypertrophy, grade iii diastolic dysfunction suggestive of elevated left atrial filling pressure.On (b)(6) 2016, urine cobalt level was 49.1 mcg/l and blood cobalt level was 4.8 mcg/l.On (b)(6) 2017, the right tha was revised.Revision implant used was a stryker polyethylene liner 36mm diameter eccentric (+6) and 36mm +4 delta option ceramic head.The old stem was sound and was in about 20 degrees of anteversion, the trunnion, and head bore showed marked corrosion.Posterior capsule was intact but had thickened fish-flesh appearance, anterior capsule was intact but was also thickened, abduction tendons were completely involved requiring debridement and repair and trochanteric bursa was involved and was debrided.Pathology report of right hip tissue showed bone, marrow, and fibrous tissue with necrosis, chronic lymphohistiocytic inflammation and focal areas with 1-5 neutrophils per high powered field.Right hip fluid cobalt level was 1,000 mcg/l and chromium level was 480 mcg/l.Fda safety report id# (b)(4).

• Brand Name: STRYKER COCR HEAD FOR A V40 TAPER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED METAL/POLYMER, POROUS, UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPEDICS
• MDR Report Key: 9733522
• MDR Text Key: 180723871
• Report Number: MW5093125
• Device Sequence Number: 1
• Product Code: LPH
• 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: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• 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
• 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: 83 YR