MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS, LTD. BHR; ACETABULAR CUP

Device Problem Appropriate Term/Code Not Available (3191)

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

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.The patient's right hip was reportedly implanted in (b)(6) 2009 and revised in (b)(6) 2013.

Manufacturer Narrative

The devices reportedly utilised in this case were implanted in an off-label application in the usa.The bhr acetabular cup is fda approved for us 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 (bhr acetabular cup).

• Brand Name: BHR
• Type of Device: ACETABULAR CUP
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS, LTD.; 1 kingmaker court,; warwick technology park; warwick CV34 6WG; UK CV34 6WG
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS, LTD.; 1 kingmaker court,; warwick technology park; warwick CV34 6WG; UK CV34 6WG
• Manufacturer Contact: lindsay d'alessandro ; 1 kingmaker court,; warwick technology park; warwick CV34 -6WG ; UK CV34 6WG ; 4419264823
• MDR Report Key: 3603087
• MDR Text Key: 4190702
• Report Number: 3005477969-2014-00104
• 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
• Type of Report: Initial
• Report Date: 01/22/2014

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: 01/22/2014
• Initial Date FDA Received: 02/03/2014
• 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: HEMI HEAD, PART AND LOT# UNKNOWN; MODULAR HEAD SLEEVE, PART AND LOT# UNKNOWN; FEMORAL STEM, PART AND LOT# UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention