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

Catalog Number 71335860

Device Problem Metal Shedding Debris (1804)

Patient Problems Host-Tissue Reaction (1297); Complaint, Ill-Defined (2331); Toxicity (2333)

Event Date 02/10/2015

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to metallosis, elevated metal ion levels (exact values not provided to the manufacturer) and a soft tissue reaction.The femoral stem remains implanted.

Manufacturer Narrative

Manufacturer Narrative

• 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: 4523644
• MDR Text Key: 5357386
• Report Number: 3005477969-2015-00046
• 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: 02/18/2015

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: 08/31/2013
• Device Catalogue Number: 71335860
• Device Lot Number: 08CW15976 047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 02/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/29/2015
• 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
• Patient Sequence Number: 1
• Treatment: SPHERICAL HEAD SCREW # 71332550, # 03MM11404; FEMORAL STEM, # 71357106, LOT # 07EM01155A; ACETABULAR SHELL, # 71331960 LOT # 08BM01276A; MODULAR SLEEVE, # 74222100, LOT # 08FW17503
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR