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

Device Problems Unstable (1667); Positioning Problem (3009)

Patient Problem Pain (1994)

Event Date 10/24/2012

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported that left hip revision surgery was performed due to pain and hip instability.The devices were implanted in 2004.Metallosis reportedly noted during procedure.

Manufacturer Narrative

• Brand Name: BHR ACETABULAR CUP
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• 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: 5034953
• MDR Text Key: 24255135
• Report Number: 3005477969-2015-00241
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Followup,Followup
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• 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: 08/19/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR