MAUDE Adverse Event Report: ZIMMER BIOMET BIOMET MAGNUM METAL-ON-METAL HIP REPLACEMENT WITH 46 MM OD SOCKETS AND 40 MM HEA; PROSTHESIS, HIP, SEMI-CONSTRAINED(METAL UNCEMENTED ACETABULAR COMPONENT)

Device Problem Corroded (1131)

Patient Problems Emotional Changes (1831); Fatigue (1849); Granuloma (1876); Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Neuropathy (1983); Pain (1994); Burning Sensation (2146); Dizziness (2194); Toxicity (2333); Osteolysis (2377); Irritability (2421); Shaking/Tremors (2515); Sleep Dysfunction (2517)

Event Date 10/15/2018

Event Type  Injury  

Event Description

'3772_mom_biomet / magnum pt had bilateral biomet magnum metal-on-metal hip replacements with 46 mm od sockets and 40 mm heads with taper lock stems.The left tha was implanted on (b)(6) 2007 and the right hip was implanted on (b)(6) 2009.She did not have any problems after her left hip replacement but developed a burning pain at both legs about 4 months following her right hip replacement.She also eventually developed tenderness at both greater trochanters and groin pain with hip flexion.On (b)(6) 2018, she had a whole blood cobalt level of 4.3 mcg/l.On plain x-rays made on (b)(6) 2018, there was evidence of significant osteolysis of both proximal femurs with absorption of both calcar areas along the lateral shoulders of the femoral components.Pt reports allergy to metal, including cobalt.She also developed onset of several neurological and possible cardiovascular problems, including: tremor of the hands, dizziness and unsteadiness, forgetfulness, increased irritability and mood swings, trouble sleeping, increased pain, fatigue, and burning peripheral neuropathy of both thighs and the right hand.Neuro q analysis of her fdg pet brain showed mild general and focal hypometabolism in a pattern consistent with chronic toxic encephalomyopathy.On (b)(6) 2018, it was found that her blood cobalt level was 3.5 mcg/l and her urine cobalt level was 14.8 mcg/l.On (b)(6) 2019 her left tha was revised for failure of cementless left total hip arthroplasty secondary to metallosis and pseudotumor formation.The revision was performed by dr james p.Crutcher.In his operative report, he documents that following findings: "the pt had an extremely large encapsulated pseudotumor adjacent to the posterior capsule of the hip joint.This was one of the largest i have seen.It measured 7x 5 x 4 cm before its attachment to the hip joint.It was filled with dark stained joint fluid.The pt also had large amounts of granulomanus debris in the hip joint space.There was only a small amount of bone loss in the medical calcar of the femur.Otherwise, the femur appeared to be intact.The femoral component was well fixed and in about 12 degrees of anteversion.There was some fretting corrosion on the trunnion of the femoral component after the head was removed.I could not tell if the corrosion debris came from the trunnion side or the femoral head side.There was no visible wear on the articulating surface of the resurfacing acetabular component.After the acetabular component was safely removed, there were areas of segmental bone loss and cavitary bone loss, primarily medially where there was a large area of contained cavitary bone loss and the posterior superiorly where there was some segmental loss of bone in the superior aspect of the posterior wall.Fda safety report id# (b)(4).

• Brand Name: BIOMET MAGNUM METAL-ON-METAL HIP REPLACEMENT WITH 46 MM OD SOCKETS AND 40 MM HEA
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED(METAL UNCEMENTED ACETABULAR COMPONENT)
• Manufacturer (Section D): ZIMMER BIOMET; warsaw IN
• MDR Report Key: 9627105
• MDR Text Key: 176451243
• Report Number: MW5092465
• Device Sequence Number: 1
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• 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: 58 YR
• Patient Weight: 100