MAUDE Adverse Event Report: SMITH & NEPHEW BHR; ACETABULAR CUP

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Skin Discoloration (2074); Sleep Dysfunction (2517); Cognitive Changes (2551)

Event Date 04/29/2013

Event Type  Injury  

Event Description

It was reported that revision surgery was performed.Pain in hips, thighs, shins, feet and soles of feet reported.General health deterioration, skin discolouration, sleep, concentration and memory problems reported.Around (b)(6) 2012 an effusion in hip detected.

• Brand Name: BHR
• Type of Device: ACETABULAR CUP
• Manufacturer (Section D): SMITH & NEPHEW; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: michael simmonds ; 4419264823
• MDR Report Key: 3809563
• MDR Text Key: 4385321
• Report Number: 3005477969-2014-00325
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2014
• 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: 05/06/2014
• 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: FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR