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

Catalog Number 71335854

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

Patient Problems Foreign Body Reaction (1868); Chemical Exposure (2570); Test Result (2695)

Event Date 05/06/2015

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to a soft tissue reaction and elevated metal ions.The femoral stem remains 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 ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001 ; 4419264823
• MDR Report Key: 4768297
• MDR Text Key: 19090349
• Report Number: 3005477969-2015-00148
• 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,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2015
• 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: 71335854
• Device Lot Number: 08AW15261
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, # (B)(4), LOT # 07JM03276A; MODULAR SLEEVE, # (B)(4), LOT # 08EW16965; ACETABULAR SHELL, # (B)(4), LOT # 08FM17512A
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 83