MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CONTOUR RECONSTRUCTION RING; PROSTHESIS, HIP, ACETABULAR MESH

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

While performing a literature review (goodman s, saastamoinen h, shasha n, gross a.Complications of ilioischial reconstruction rings in revision total hip arthroplasty.The journal of arthroplasty.2004;19(4):436-446.) for the contour reconstruction rings, the following incident was found: superior flange fracture.

• Brand Name: CONTOUR RECONSTRUCTION RING
• Type of Device: PROSTHESIS, HIP, ACETABULAR MESH
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: claudia de santis ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6067057
• MDR Text Key: 58765074
• Report Number: 1020279-2016-00838
• Device Sequence Number: 1
• Product Code: JDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention