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); Weakness (2145); Chemical Exposure (2570); Test Result (2695)

Event Date 12/09/2013

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to pain, weakness of the legs and hips, elevated cobalt and chromium levels, and fluid accumulations around the hip.It was reported that following implantation, the patient's wounds healed without infection, that x-rays showed the hip replacement to be properly positioned and the hip prostheses suffered no impacts.

Manufacturer Narrative

The above combination of devices constitutes an off label application in the united states.

• 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: 3627850
• MDR Text Key: 18570156
• Report Number: 3005477969-2014-00159
• 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: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2014
• 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: 02/12/2014
• 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: FEMORAL STEM, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN; ACETABULAR SHELL, PART AND LOT # UNKNOWN; HEMI HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention