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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 10/21/2013

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to failure of the devices.The type of failure was not reported.

• Brand Name: R3
• Type of Device: COCR ACETABULAR LINER
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house spa park; harrison way; leamingon spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house spa park; harrison way; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: jennifer ferguson ; 4419264823
• MDR Report Key: 3951286
• MDR Text Key: 4608272
• Report Number: 3005477969-2014-00413
• 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
• Type of Report: Initial
• Report Date: 07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2014
• 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: 07/17/2014
• 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 NUMBERS UNKNOWN; FEMORAL STEM, PART AND LOT NUMBERS UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention