MAUDE Adverse Event Report: BIOMET, INC. M2A MAGNUM 38 MM MOM; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Inflammation (1932); Memory Loss/Impairment (1958); Pain (1994); Rash (2033); Tinnitus (2103); Balance Problems (4401); Unspecified Immune System Problem (4435); Muscle/Tendon Damage (4532); Skin Inflammation/ Irritation (4545)

Event Date 06/04/2009

Event Type  Injury  

Event Description

2009 surgery with "biomet zimmermann" mom tha m2a magnum 38 mm resulting in long medical care post surgical to date.Surgeon won't see me, leaving me to guess why my headaches are severe.Full body inflammation as in tendonitis in every tendon.Balance issues, memory issues, pain, more systemically problems than ever before pre surgery.Major skin rashes with inflammation.The most severe is immune system issues which started immediately.Serum cobalt levels 0.9, 0.7, 0.5, 0.5.No activity levels go down, with some activity levels go back up.Ringing in ears more like a frequency that wont go away.Several specialist from rheumatologist, neurologist, spine specialist, dermatologist, family dr.Cardiologist and vascular surgeon all advising removal of metal on metal m2a magnum.My surgeon whom did it is pushing me aside.I'm looking for someone else now for several years.Insurance wont pay, i must pay out of pocket.I don't have over 100 k.Device is bad.Faulty.I've written fda before and spent numerous hours trying to help rid my health issues all chronic since surgery.All in bio of device problems.

• Brand Name: M2A MAGNUM 38 MM MOM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
• Manufacturer (Section D): BIOMET, INC.
• MDR Report Key: 16410953
• MDR Text Key: 310007240
• Report Number: MW5115063
• 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
• Report Date: 02/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White