MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121146

Device Problems Break (1069); Collapse (1099)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 05/02/2018

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to femoral neck collapse into varus.

Manufacturer Narrative

It was reported that hip revision surgery was performed due to neck collapse into varus.As of today, device return and additional information has been requested for this complaint but has not become available.Since neither the underlying medical documents nor device part details were received for investigation no thorough medical investigation, manufacturing record review and assessment of the reported event can be performed.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: RESURFACING FEMORAL HEAD 46MM
• 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: 7494737
• MDR Text Key: 107608646
• Report Number: 3005975929-2018-00152
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502780
• UDI-Public: 03596010502780
• 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: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74121146
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/02/2018
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP, # 74120152, LOT # UNKNOWN.; ACETABULAR CUP, # 74120152, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention