MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 48/54; PROSTHESIS, HIP, SM-CR, MTL/MTL, RESURFACING

Model Number 74122154

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 09/15/2020

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to an infection.A s&n spectron and bhr cup were explanted along with a competitor liner (avantage).The joint was washed out with betadine, chlorhexidine and peroxide.An a cemented 49 polarcup and cpcs were implanted.The cement was augmented with antibiotics, and the doctor will remove these implants in approximately 12 weeks and performed a 2nd stage revision thr.The patient outcome is unknown.

Manufacturer Narrative

It was reported that a revision surgery was performed.The devices involved were all used in treatment.As of today, additional information has been requested for this complaint but have not become available.Without definitive part and lot numbers a complaint history and dhr review 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.Smith and nephew has not received device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Without 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: ACETABULAR CUP HAP SIZE 48/54
• Type of Device: PROSTHESIS, HIP, SM-CR, MTL/MTL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 10660014
• MDR Text Key: 211003214
• Report Number: 3005975929-2020-00375
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74122154
• Device Catalogue Number: 74122154
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention