MAUDE Adverse Event Report: JOHNSON AND JOHNSON / DEPUY ORTHOPAEDICS, INC. DEPUY ULTRAMET METAL LINER; PINNACLE LINER-HIP

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 12/07/2002

Event Type  Injury  

Event Description

Had depuy pinnacle hip put in (b)(6) 2001.Reported pain in hip at one year evaluation to surgeon.Limping 4 years later, pain in hip growing worsen.Got in so much pain, saw orthopedist in 2007.He did not know cause of pain.Put on pain medication therapy.When news broke about defective depuy hips no orthopedist would see me.

• Brand Name: DEPUY ULTRAMET METAL LINER
• Type of Device: PINNACLE LINER-HIP
• Manufacturer (Section D): JOHNSON AND JOHNSON / DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 7850749
• MDR Text Key: 119570363
• Report Number: MW5079608
• Device Sequence Number: 2
• Product Code: JDI
• 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: 09/01/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 54 YR
• Patient Weight: 64