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

Catalog Number 71335852

Device Problem Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Toxicity (2333)

Event Date 03/02/2015

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to elevated metal ion levels and a suspected soft tissue reaction.

• 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 ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: terry mcmahon ; 970 lake carillon drive; st petersburg, FL 33716 ; 4419264823
• MDR Report Key: 4568512
• MDR Text Key: 5550306
• Report Number: 3005477969-2015-00072
• 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,company representati
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2018
• Device Catalogue Number: 71335852
• Device Lot Number: 08GW18014 002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/02/2015
• Initial Date FDA Received: 03/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2008
• 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: FEMORAL STEM, # 71357006, LOT # 07DM18272A; MODULAR HEAD, # 74222140, LOT # 08JW19089; ACETABULAR SHELL, # 71331952, LOT # 08MM10355A; MODULAR SLEEVE, # 74222100, LOT # 08KW19682
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR