MAUDE Adverse Event Report: BIOMET, INC. BIOMET METAL ON METAL HIP DEVICE WITH A TAPERLOCK STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Encephalopathy (1833); Fatigue (1849); Memory Loss/Impairment (1958); Pain (1994); Complaint, Ill-Defined (2331); Toxicity (2333)

Event Date 05/23/2016

Event Type  Injury  

Event Description

Pt id: (b)(6) on (b)(6) 2008, she received a left total hip arthroplasty.The components includes a biomet total hip system size 12.5 mm x 145mm long taper lock femoral stem, 54mm outer diameter universal tourniquet bearing shell with 2-hole apical plug 432-mm head, 32-mm +0 high carbon (cobalt chrome) femoral head, two 6.5mm cancellous bone screws.This is a metal bearing.In 2012, she developed progressive pain in the left hip especially with sitting.Metal suppression mri made on (b)(6) 2016, showed a large fluid collection that drapes along the left iliopsoas tendon at the level of the hip measuring 10cm in craniocaudal diameter x a total of 6cm in transverse diameter x3m in depth.On (b)(6) 2016, cobalt plasma level was 4.8 mcg/l.On (b)(6) 2016, urine cobalt level was 13 mcg/l and blood cobalt level is 4.4 mcg/l.On (b)(6) 2016, her urine cobalt level was 9.7 mcg/l.Since the left tha in 2007, she has experienced sudden onset of extreme fatigue and hypersomnia, mood disorder, dyspnea on exertion, poor memory requiring regular note taking.Echocardiogram made on (b)(6) 2016, was notable for mild diastolic dysfunction and mild left ventricular hypertrophy.Neuro q analysis of her fdg pet brain scan was notable for focal and global hypometabolism suggestive of chronic toxic encephalopathy.Fda safety report id # (b)(4).

• Brand Name: BIOMET METAL ON METAL HIP DEVICE WITH A TAPERLOCK STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): BIOMET, INC.; warsaw IN
• MDR Report Key: 9671357
• MDR Text Key: 178014360
• Report Number: MW5092753
• 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: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• 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
• Patient Age: 62 YR
• Patient Weight: 104