MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD FEMORAL HEAD 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74123152

Device Problems Mechanical Problem (1384); Structural Problem (2506)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 12/13/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to neck-narrow of a resurfacing implant.

Manufacturer Narrative

It was reported that a revision surgery is scheduled to be performed due to neck-narrow of a resurfacing implant.As of today, device return and additional information has been requested for this complaint but has not become available.No batch/lot information was received for the bhr head.Additionally, the bhr head batch/lot information could not be sourced through sap searches.In the absence of the actual devices, the production records were reviewed for the bhr cup reportedly involved in this incident.All the known released devices involved met manufacturing specifications at the time of production.The available medical documents were reviewed.Based on the information provided from the product manager for hip recon in italy a revision surgery has not occurred.The patient is awaiting a custom made liner for the bhr revision from uk.One undated x-ray was provided, which shows a bhr implant with no radiolucencies.If there is narrowing around the femoral neck it can¿t be assessed to what extent without comparison images.There is not sufficient relevant clinical information to conduct a thorough clinical analysis of the reported issue.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: FEMORAL HEAD 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV313 HL; UK CV313HL
• MDR Report Key: 8196343
• MDR Text Key: 131419476
• Report Number: 3005975929-2018-00555
• 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: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74123152
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP 74122158 LOT 17EW21950; UNKNOWN BHR DEVICE/ UNKNOWN LOT; UNKNOWN BHR DEVICE/ UNKNOWN LOT
• Patient Outcome(s): Hospitalization; Required Intervention