MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP HAP 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120154

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Synovitis (2094); Toxicity (2333)

Event Date 06/24/2015

Event Type  Injury  

Event Description

Bhr revision due to persistent hip synovitis and metallosis.

• Brand Name: BHR ACETABULAR CUP HAP 54MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; 1 kingmaker court; gallows hill CV34 6WG; UK CV34 6WG
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora, spa park; harrison way; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: terry mcmahon ; 970 lake carillon dr; st petersburg, FL 33716
• MDR Report Key: 4944525
• MDR Text Key: 6253730
• Report Number: 3005477969-2015-00197
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/09/2015

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
• Device Expiration Date: 03/31/2008
• Device Model Number: 74120154
• Device Catalogue Number: 74120154
• Device Lot Number: 28091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/09/2015
• Initial Date FDA Received: 07/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/12/2015
• 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
• Patient Age: 74 YR