MAUDE Adverse Event Report: ZIMMER / BIOMET, INC. BIOMET MAGNUM METAL-METAL PRESS-FIT CUP TAPERLOC LATERALIZED OFFSET; PROSTHESIS, HIP

Model Number 1577448, 139254,15-10326, US157854

Device Problem Mechanical Problem (1384)

Patient Problems Pain (1994); Thyroid Problems (2102); Toxicity (2333)

Event Date 11/20/2018

Event Type  Injury  

Event Description

I have 2 biomet mm hips.I was recently diagnosed with goiter that may have been caused by the cobalt levels.I have had bursitis on the left for several years and in the last year have had a different pain becoming severe in last year that i saw my primary for help (b)(6) 2018.I had 2 episodes of the hip locking up last winter.I had my primary get a set of metal levels 4 months ago because i read on the internet that these were a problem.I not had any done for almost 5 years from the original orthopedic dr.Why weren't they recalled? i want to know why wasn't i notified that these hips had these problems and surveillance was needed? goiter diagnosed by us on (b)(6) 2019, further studies being done.Getting an mar, mri (b)(6) 2019 and seeing surgeon next week and plan to replace the left one soon.Fda safety report id# (b)(4).

Event Description

Add'l info received from reporter on 05/15/2019 for mw5086002: pt has been diagnosed with metallosis, left hip pain, goiter, and has episodes of left hip locking up.Reporter also provided ref numbers for the left hip system.

• Brand Name: BIOMET MAGNUM METAL-METAL PRESS-FIT CUP TAPERLOC LATERALIZED OFFSET
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER / BIOMET, INC.
• MDR Report Key: 8531639
• MDR Text Key: 142675370
• Report Number: MW5086002
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 04/17/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1577448, 139254,15-10326, US157854
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 68 YR
• Patient Weight: 79