MAUDE Adverse Event Report: ZIMMER BIOMET ZIMMER DUROM METAL-ON-METAL HIP DEVICE; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT

Device Problems Corroded (1131); Material Fragmentation (1261)

Patient Problems Dyspnea (1816); Emotional Changes (1831); Encephalopathy (1833); Fall (1848); Fatigue (1849); Bone Fracture(s) (1870); Inflammation (1932); Itching Sensation (1943); Memory Loss/Impairment (1958); Pain (1994); Visual Impairment (2138); Burning Sensation (2146); Myalgia (2238); Arthralgia (2355); Depression (2361); Joint Dislocation (2374); Shaking/Tremors (2515); Cognitive Changes (2551); Test Result (2695)

Event Date 07/14/2017

Event Type  Injury  

Event Description

Pt id: (b)(6) on (b)(6) 2007, she received a right metal-on-metal total hip arthroplasty for degenerative osteoarthritis of the right hip.The components were a zimmer size 11 press fit m/l taper stem, with a 44mm cocr mallory head, and a cocr size 50 durom acetabular component.In 2017, she began reporting right hip pain, but this was somewhat masked by pain from her severely arthritic and stenotic back.Metal suppression mri of the right hip done in (b)(6) 2016 did not show any adverse reaction to metallic debris.She has developed mood disorder and depression, which began following her right hip replacement.She has also developed forgetfulness, diminished ability to focus, tremor, mood changes, shortness of breath, vision changes, itching/burning at bilateral feet, diminished pain tolerance/increased pain, fatigue, myalgia, arthralgia and balance issues.On (b)(6) 2017, her whole blood cobalt level was 1.5 mcg/l.On (b)(6) 2018, urine cobalt level was 7.5 mcg/l and blood cobalt level was 2.0 mcg/l.On (b)(6) 2018, urine cobalt level was 14mcg/l.On (b)(6) 2018, whole blood cobalt level was 1.4 mcg/l and urine cobalt level was 6.9mcg/l.On (b)(6) 2018,urine cobalt level was 7.5 mcg/l and blood cobalt level was 1.5mcg/l.Cobalt chelation with n-acetyl cysteine was attempted but was not effective.Her fdg pet brain scan with neuroq analysis showed abnormal general and focal hypometabolism in a pattern consistent with chronic toxic encephalopathy.Given her progressive symptoms and elected to have the right metal-on-metal hip revised on (b)(6) 2018.The durum metal-on-metal articulation was revised to a zimmer continuum multiple hole size 54 socket with 5 screws and a delta ceramic option size 36mm +0 head.The old stem was sound and in about 20 degrees of anteversion, the trunnion and head bore showed moderate corrosion.There was slight metallosis present around the hip.There was mild lysis of the acetabular component.The posterior capsule was attenuated but intact, the anterior capsule and abduction tendons were intact, and the trochanteric bursa was not effused.Pathology report of frozen section of right hip capsular and synovium described benign soft tissue with synovial hyperplasia, histiocytic infiltrates, mild chronic inflammation, and fibrinous debris with no evidence of suppurative inflammation no avail.Fluid was collected from the right hip and diluted 1:3, and the cobalt level of this diluted fluid was 43 mcg/l.On (b)(6) 2019, she fell and sustained and anterior dislocation and acetabular fracture.This second revision operation involved implanting a gap cage, sloof impaction graft, and a cemented simmer constrained liner with modular revision of the femoral head to a 36 mm +0 ceramic.On (b)(6) 2019, her urine cobalt was 1.0 mcg/l and blood cobalt was 0.6mcg/l.Fda safety report id # (b)(4).

• Brand Name: ZIMMER DUROM METAL-ON-METAL HIP DEVICE
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT
• Manufacturer (Section D): ZIMMER BIOMET; warsaw IN
• MDR Report Key: 9706446
• MDR Text Key: 180101073
• Report Number: MW5092975
• Device Sequence Number: 2
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2020
• 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: 67 YR
• Patient Weight: 100