MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 PRIMARY LINERS CO; R3 46MM ID INTL COCR LINER 58MM

Model Number 71335858

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

Patient Problems Swelling (2091); Chemical Exposure (2570); Test Result (2695)

Event Date 11/12/2014

Event Type  Injury  

Event Description

It was reported that a r3 mom hip was revised due to high metal ion levels and pseudotumour.

• Brand Name: R3 PRIMARY LINERS CO
• Type of Device: R3 46MM ID INTL COCR LINER 58MM
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; 1 kingmaker court; gallows hill CV34 6WG; UK CV34 6WG
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora, spa park; harrison way; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: terry mcmahon ; 970 lake carillon dr; baar; st petersburg, FL 33716 ; 0628320660
• MDR Report Key: 4257545
• MDR Text Key: 4990822
• Report Number: 3005477969-2014-00566
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: 71335858
• Device Catalogue Number: 71335858
• Device Lot Number: 08CW16368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: MW1209
• Patient Sequence Number: 1
• Treatment: R3 HA ACET SHELL 58MM: (B)(4), LOT 08BM12579A; BHR MODULAR HEAD 46MM: (B)(4), LOT 08CW16185
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 38