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

Device Problem Unstable (1667)

Patient Problems Fall (1848); Myocardial Infarction (1969); Pain (1994); Rash (2033); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/16/2020

Event Type  Injury  

Event Description

The metal on metal hip by biomet caused metallosis.I had developed severe hip pain, hip instability which caused two falls that required transport by ambulance to the er.I developed skin rashes and kidney functions that dropped below normal.My pre-op testing for a hip revision surgery showed that i had a heart attack of indeterminate age.Fda safety report id# (b)(4).

• Brand Name: METAL ON METAL HIP IMPLANT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
• Manufacturer (Section D): BIOMET, INC.
• MDR Report Key: 12143198
• MDR Text Key: 261008287
• Report Number: MW5102420
• Device Sequence Number: 1
• Product Code: KWA
• 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: 07/07/2021

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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 70 YR
• Patient Weight: 58