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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Weakness (2145); Complaint, Ill-Defined (2331); Toxicity (2333)

Event Date 01/25/2013

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to failure of the devices.Pain, weakness of the legs and hips, elevated cobalt and chromium levels, and fluid accumulations were reported.

• Brand Name: R3
• Type of Device: COCR ACETABULAR LINER
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house spa park; harrison way; leamingon spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house spa park; harrison way; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: jennifer ferguson ; 4419264823
• MDR Report Key: 3985237
• MDR Text Key: 16860092
• Report Number: 3005477969-2014-00441
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/01/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/31/2014
• Initial Date FDA Received: 08/06/2014
• 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: ACETABULAR SHELL, PART AND LOT NUMBERS UNKNOWN; FEMORAL HEAD, PART AND LOT NUMBERS UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention