MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. DEPUY CERAMIC HIP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 07/22/2021

Event Type  Injury  

Event Description

My right hip was replaced in 2018.I received a depuy hip.It is now rubbing and squeaking.I've been told that i need surgery to replace the ceramic cup because it is showing signs of wearing out.It's only been 3 years.I thought it was supposed to last for 10 years.Fda safety report id # (b)(4).

• Brand Name: DEPUY CERAMIC HIP
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 12313583
• MDR Text Key: 266488560
• Report Number: MW5103210
• Device Sequence Number: 1
• Product Code: MRA
• 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: 08/09/2021

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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 76