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

Catalog Number 71335854

Device Problems Metal Shedding Debris (1804); Material Integrity Problem (2978)

Patient Problem Reaction (2414)

Event Date 02/07/2014

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to an adverse reaction to metal debris.

• 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; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: michael simmonds ; 4419264823
• MDR Report Key: 3666488
• MDR Text Key: 4346887
• Report Number: 3005477969-2014-00178
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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,Followup,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2013
• Device Catalogue Number: 71335854
• Device Lot Number: 09CW22574 038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2008
• 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, # 74222142, LOT # 09CW22574 038; FEMORAL HEAD, PART AND LOT # UNKNOWN; ACETABULAR SHELL, PART AND LOT # UNKNOWN; ACETABULAR SHELL, # 71331854, LOT # 09EM16604; MODULAR SLEEVE, # 74222100, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 74