MAUDE Adverse Event Report: JOHNSON AND JOHNSON/ DEPUY SYNTHES, INC. DEPUY PINNACLE; PROSTHESIS, HIP

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 03/24/2015

Event Type  Injury  

Event Description

Depuy pinnacle liner dissociation.The polyethylene liner dissociated from the modular acetabular component.The patient returned to the operating room for revision surgery after this was noted on physical exam and radiographic imaging.

• Brand Name: DEPUY PINNACLE
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): JOHNSON AND JOHNSON/ DEPUY SYNTHES, INC.
• MDR Report Key: 7637748
• MDR Text Key: 112452610
• Report Number: MW5078046
• Device Sequence Number: 1
• 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: Physician
• Type of Report: Initial
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR