MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS BHR HEMI HEAD 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL

Catalog Number 74122544

Device Problem Insufficient Information (3190)

Patient Problem Rash (2033)

Event Date 08/17/2015

Event Type  Death  

Event Description

It was reported that left hip revision surgery was performed due to rashes over both legs, pain in left hip and elevated ion blood levels.

Manufacturer Narrative

(b)(4).

• Brand Name: BHR HEMI HEAD 44MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS; 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, FL 5001 ; SZ 5001
• MDR Report Key: 5143835
• MDR Text Key: 28023238
• Report Number: 3005477969-2015-00275
• 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,other
• Reporter Occupation: Attorney
• Type of Report: Followup
• Report Date: 10/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2011
• Device Catalogue Number: 74122544
• Device Lot Number: 08CW16094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2015
• Date Device Manufactured: 11/14/2006
• 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
• Patient Outcome(s): Hospitalization; Required Intervention