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

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 07/09/2013

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to pain, weakness of the legs and hips, and fluid accumulations around the hip.

Manufacturer Narrative

The devices reportedly utilised in this case were implanted in an off-label application in the usa.The r3 cocr acetabular liner is fda approved for use only with a bhr resurfacing femoral head.The hemi-head (large diameter cocr femoral head) is only approved for use by fda when attached to a smith & nephew femoral stem for articulation on native bone, not on an acetabular component (r3 cocr acetabular liner).

• Brand Name: R3
• Type of Device: COCR ACETABULAR LINER
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS, LTD.; aurora house, spa park; harrison way; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS, LTD.; aurora house, spa park; harrison way; leamington spa CV34 6WG; UK CV34 6WG
• Manufacturer Contact: lindsay d'alessandro ; aurora house, spa park; harrison way; leamington spa CV31 -3HL ; UK CV31 3HL ; 4419264823
• MDR Report Key: 3769849
• MDR Text Key: 20270944
• Report Number: 3005477969-2014-00277
• 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: Attorney
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• 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
• Date Manufacturer Received: 04/16/2014
• 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# UNKNOWN; HEMI HEAD, PART AND LOT# UNKNOWN; FEMORAL STEM, PART AND LOT# UNKNOWN; FEMORAL SLEEVE, PART AND LOT# UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention