MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD. R3; COCR ACETABULAR LINER

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Pain (1994); Swelling (2091); Weakness (2145); Chemical Exposure (2570); Test Result (2695)

Event Date 04/29/2013

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to elevated cobalt and chromium levels, pain, weakness of the legs and hips, and fluid accumulations around the hip.

• Brand Name: R3
• Type of Device: COCR ACETABULAR LINER
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD.; 1 kingmaker court; warwick technology park; warwick CV34 6WG; UK CV34 6WG
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS, LTD.; 1 kingmaker court; warwick technology park; warwick CV34 6WG; UK CV34 6WG
• Manufacturer Contact: michael simmonds ; 4419264823
• MDR Report Key: 3567179
• MDR Text Key: 4072745
• Report Number: 3005477969-2014-00018
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• 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: 01/08/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACETABULAR SHELL, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention