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

Catalog Number 71341160

Device Problem Insufficient Information (3190)

Patient Problems Muscle Weakness (1967); Pain (1994); Toxicity (2333)

Event Date 02/10/2014

Event Type  Injury  

Event Description

It was reported that revision surgery will be performed in may 2014 due to pain, weakness of the legs and hips, elevated cobalt and chromium levels, and fluid accumulations around the hip.

Event Description

It was reported that revision surgery was performed.It was determined that the patient had an infection.

Manufacturer Narrative

The above combination of devices constitutes an off label application in the united states.

• Brand Name: R3
• Type of Device: COCR ACETABULAR LINER
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; 1 kingmaker court; warwick technology park; warwick CV34 6WG; UK CV34 6WG
• Manufacturer (Section G): SMITH & NEPHEW; 1 kingmaker court; warwick technology park; warwick CV34 6WG; UK CV34 6WG
• Manufacturer Contact: michael simmonds ; 4419264823
• MDR Report Key: 3607954
• MDR Text Key: 4153986
• Report Number: 3005477969-2014-00146
• 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,Followup
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 71341160
• Device Lot Number: 08FW17421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2008
• 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: FEMORAL STEM, # 71357007, LOT # 09HM01107A; FEMORAL STEM, PART AND LOT # UNKNOWN; HEMI HEAD, # 74122548, LOT # 08KW19324; SPHERICAL SCREW, # 71332525, LOT # 08CT17875; ACETABULAR SHELL, # 71335560, LOT # 09CM17092; MODULAR SLEEVE, # 74222100, LOT # 09AW20993; ACETABULAR SHELL, PART AND LOT # UNKNOWN; HEMI HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR