MAUDE Adverse Event Report: BIOMET, INC. BIOMET M2A METAL ON METAL HIP SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)

Patient Problems Hair Loss (1877); Hearing Impairment (1881); Memory Loss/Impairment (1958); Tinnitus (2103); Visual Disturbances (2140); Dizziness (2194); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

Experiencing the following symptoms from metal on metal hip implants; original surgeries 2001 and 2003.Elevated cobalt and chromium levels attributing to: lightheadedness, dizziness, loss of balance, tinnitus, visual changes, hearing changes, memory loss, brittle nails and teeth, hair loss.M2a metal on metal hip implants: taper lock stem, metal cup, femoral head.Left hip revision (b)(6) 2023 to remove metal on metal hip implant.

• Brand Name: BIOMET M2A METAL ON METAL HIP SYSTEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
• Manufacturer (Section D): BIOMET, INC.
• MDR Report Key: 18487000
• MDR Text Key: 332783072
• Report Number: MW5150098
• 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: 01/06/2024

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: 01/09/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White