MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABLR CUP HAP 44MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120144

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Toxicity (2333); Injury (2348); Ambulation Difficulties (2544)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that a right hip revision will be performed (b)(6) 2020 due to persistent hip pain, loss of mobility, difficulty walking, clunking and elevated chromium and cobalt levels.

Manufacturer Narrative

It was reported that a right hip revision surgery will be performed due to persistent hip pain, loss of mobility, difficulty walking, clunking and elevated chromium and cobalt levels.The devices involved were all used in treatment.As of today additional information have been requested for this complaint but have not become available.Without definitive part and lot numbers a complaint history, dhr review, device labelling and risk assessment cannot be performed for the devices involved.Should the lot/batch/serial number become available at a later date then the complaint history task will be re-opened and completed.No medical documents were received.The reported event cannot be assessed and a thorough medical assessment cannot be performed.If notification is received that additional medical documentation has been provided, this complaint will be re-evaluated and a thorough medical assessment rendered.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: ACETABLR CUP HAP 44MM W/ IMPTR
• 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: 9872446
• MDR Text Key: 184714973
• Report Number: 3005975929-2020-00087
• 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
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/14/2021

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: No Information
• Device Model Number: 74120144
• Device Catalogue Number: 74120144
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/24/2020
• Supplement Dates Manufacturer Received: 09/09/2020; 02/17/2021; 03/31/2021
• Supplement Dates FDA Received: 09/10/2020; 02/28/2021; 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention