MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 ACETABULAR LINER 64MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL,

Catalog Number 71335864

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

Udi/di: undetermined.

Event Description

It was reported that left hip revision surgery was performed due to infection.

• Brand Name: R3 ACETABULAR LINER 64MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL,
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; 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: 5083465
• MDR Text Key: 25994093
• Report Number: 3005477969-2015-00258
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 09/01/2015

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 Catalogue Number: 71335864
• Device Lot Number: 07KW14523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/11/2016
• 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