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

Device Problems Vibration (1674); Noise, Audible (3273)

Patient Problems Pain (1994); Tinnitus (2103); Blurred Vision (2137); Discomfort (2330); Toxicity (2333); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 08/01/2018

Event Type  Injury  

Event Description

Reporter called to report clicking, popping, grinding vibration, electrical pulsation in the back of the left leg, tinnitus, blurry vision, ambulation difficulties, and chronic pain due to his hip implants.Also, was diagnosed with heavy metal blood poisoning that lead to a revision of both hips.Reporter stated that he was on short term disability and on long term due to chronic pain, discomfort and capsule deterioration of the right hip.

• Brand Name: M2A MAGNUM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
• Manufacturer (Section D): BIOMET, INC.
• MDR Report Key: 8407646
• MDR Text Key: 138415156
• Report Number: MW5084793
• Device Sequence Number: 3
• 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: 03/08/2019
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 48 YR
• Patient Weight: 91