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

Catalog Number 71335852

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

Patient Problems Pain (1994); Test Result (2695)

Event Date 06/05/2014

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to groin pain and increased ion levels.The acetabular shell and femoral stem remained implanted.

• Brand Name: R3
• Type of Device: COCR ACETABULAR LINER
• Manufacturer (Section D): SMITH & NEPHEW; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: michael simmonds ; 4419264823
• MDR Report Key: 3852837
• MDR Text Key: 19800064
• Report Number: 3005477969-2014-00360
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 71335852
• Device Lot Number: 08AW15257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2008
• 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: MODULAR HEAD, # 74222140, LOT # 07JW13771; MODULAR SLEEVE, # 74222300, LOT # 08JW19037; FEMORAL STEM, PART AND LOT # UNKNOWN; ACETABULAR SHELL, # 71335552, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 60