MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 44/50; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74122150

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 01/20/2020

Event Type  Injury  

Event Description

It was reported that a washout (incision and drain) on an infected patient with a 44 bhr head and 50 bhr cup.No implants were explanted.The infection was due to p.Acne.

Manufacturer Narrative

It was reported that a washout (incision and drain) was performed on an infected patient with a 44 bhr head and 50 bhr cup.No implants were explanted.The infection was due to p.Acne.As of today, additional information has been requested for this complaint but has not become available.Without definitive part/lot numbers a complete a complaint history review cannot be performed for the devices involved.A review of the complaint history was performed using the part numbers for a femoral head 44mm and acetabular cup 50mm in search of complaints involving infection throughout the lifetime of the product.Similar complaints have been identified and this failure will continue to be monitored.No part/lot numbers were provided; hence a documentation review could not be completed.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as a result of the reported event.No medical documents were supplied.However, the infection was due to p.Acne and was not related to a mal-performance of the implant.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.However, based on the available information, the root cause for the revision was the p.Acne which is not related to the product.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 44/50
• 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: 9659574
• MDR Text Key: 177398588
• Report Number: 3005975929-2020-00033
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552273
• UDI-Public: 03596010552273
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 74122150
• Device Catalogue Number: 74122150
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74123144 FEMORAL HEAD 44MM.
• Patient Outcome(s): Hospitalization; Required Intervention