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

Device Problems Peeled/Delaminated (1454); Patient-Device Incompatibility (2682)

Patient Problems Foreign Body In Patient (2687); Test Result (2695)

Event Date 10/22/2018

Event Type  Injury  

Event Description

This is an ongoing problem caused by cobalt/chromium depuy hip implant.It did not start on a specific date.Metal on metal hip replacement.I am an active person walking and bike riding a couple thousand miles per year, so there is a lot of metal debris.

• Brand Name: DEPUY HIP IMPLANT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, (METAL UNCEMENTED ACETABULAR COMPONENT)
• Manufacturer (Section D): DEPUY SYNTHES, INC.
• MDR Report Key: 8102062
• MDR Text Key: 128557498
• Report Number: MW5081597
• 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: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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): Hospitalization; Other; Disability
• Patient Age: 75 YR
• Patient Weight: 70