MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 56MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120156

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2019

Event Type  Injury  

Event Description

It was reported a hip revision surgery due to femoral neck fracture.Head and cup explanted.

Manufacturer Narrative

It was reported that hip revision surgery was performed due to femoral neck fracture.During the revision, the bhr cup, femoral head were removed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the cup, head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the cup and head.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as a result of the reported event.The available medical documents were reviewed.It was reported that a hip revision surgery was done due to femoral neck fracture and the head and cup were explanted.The xray image shows the femoral component loosening on the right side over time, but no root cause can be concluded based on the information provided.In the event additional medical/clinical records are received, the clinical task will be re-opened and a thorough assessment will be rendered at that time.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: ACETLR CUP HAP 56MM 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: 9183937
• MDR Text Key: 162364172
• Report Number: 3005975929-2019-00356
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502599
• UDI-Public: 03596010502599
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2023
• Device Model Number: 74120156
• Device Catalogue Number: 74120156
• Device Lot Number: 18AW07906
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RESURFACING FEM HEAD 50MM 74121150/18AW16143.
• Patient Outcome(s): Hospitalization; Required Intervention