MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 COCR LINER 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFAC

Catalog Number 71341150

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Swelling (2091); Toxicity (2333)

Event Date 03/22/2012

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported that revision surgery was performed due to pain and swelling in 2011.After implantation in 2010 the patient began to have problems.Patient was tested for metallosis and has confirmed reportedly elevated levels.

Event Description

It was claimed by the patient that she suffered a hip dislocation in the fall of 2012.The documents provided to support this claim have been received and examined.Revision surgery had taken place on (b)(6) 2012 with total left hip replacement comprising acetabular and femoral head/neck components, and repair of abductor muscle rupture at left hip.Reason for revision is metallosis after left total hip replacement.Test data summary is given in this report's test data.

• Brand Name: R3 COCR LINER 50MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFAC
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; 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
• MDR Report Key: 5640193
• MDR Text Key: 44690201
• Report Number: 3005477969-2016-00098
• 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
• Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 71341150
• Device Lot Number: 09AW20940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACETABULAR SHELL, # 71331950, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR