MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 50MM; ACETLR CUP HAP 56MM W/ IMPTR

Catalog Number 74121150

Device Problems Device Operates Differently Than Expected (2913); Patient Device Interaction Problem (4001)

Patient Problems Necrosis (1971); Hip Fracture (2349); No Information (3190)

Event Date 04/19/2007

Event Type  Injury  

Event Description

It was reported the right hip failed, implantation occured (b)(6) 2007.Reason as to failure is unclear cup was retained and head was replaced, stem and modular sleeve added.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to femoral neck fracture.During the revision the bhr head was removed and the bhr cup remained implanted.As of today, device return and additional information has been requested for this complaint but has not become available.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.The available medical documents were reviewed.Review of the provided implantation report did not reveal any inconsistencies related to the surgical technique that could explain the later revision.Without x-rays it remains unclear whether the cup was implanted vertically or it changed the position during the time in-vivo.According to the provided revision report, the acetabular cup was found slightly vertical and slightly uncovered laterally.The post-operative diagnosis was neck fracture and probably avascular necrosis.As no additional details on the avascular necrosis was provided and x-rays are unavailable the reason for the neck fracture cannot be determined and other possible contributing factors cannot be excluded (e.G.Notching, impingement related to the cup position, valgus femoral component etc.).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.Concomitant medical products: 74120156/acetlr cup hap 56mm w/ imptr/67069.

Event Description

It was reported that revision surgery was performed to neck fracture; probable avascular necrosis of femoral head.

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21cfr, part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

• Brand Name: RESURFACING FEMORAL HEAD 50MM
• Type of Device: ACETLR CUP HAP 56MM W/ IMPTR
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 6198467
• MDR Text Key: 63092976
• Report Number: 3005975929-2016-00074
• 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: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2011
• Device Catalogue Number: 74121150
• Device Lot Number: 64900
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74120156/ACETLR CUP HAP 56MM W/ IMPTR/67069; RESURFACING FEMORAL HEAD#74121150, LOT64900; RESURFACING FEMORAL HEAD#74121150, LOT64900
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR