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

Catalog Number 74120144

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 10/30/2012

Event Type  Injury  

Event Description

It was reported a right hip revision surgery was performed due to persistent pain and discomfort in right hip, felt a warm fluid-like sensation in the hip, heard audible popping and felt a painful grinding sensation in the right hip.In addition, patient has elevated metal ion levels in blood.

Manufacturer Narrative

It has been determined that the report is a duplicate of previous submission 3005477969-2013-00558.Please disregard this submission.

• Brand Name: ACETABLR CUP HAP
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 9872271
• MDR Text Key: 184677071
• Report Number: 3005975929-2020-00083
• 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
• Type of Report: Initial,Followup
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 74120144
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention