MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74121150

Device Problems Collapse (1099); Fracture (1260)

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

Event Date 02/03/2020

Event Type  Injury  

Event Description

It was reported that a bhr hip revision surgery was performed because the femoral head collapsed.

Manufacturer Narrative

It was reported that hip revision surgery was performed.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 without definitive part/lot numbers a complete complaint history review cannot be performed for the devices involved.A review of the complaint history review was performed using the part number for femoral head 50mm in search of complaints involving "femoral head collapse" throughout the lifetime of the product.No similar complaints have been identified and will continue to be monitored.As no device batch numbers were provided for investigation, a manufacturing record review, device labelling / ifu review and risk management review could not be performed.If more information is received, this investigation will be reopened.No medical documents were received for investigation.Therefore no medical assessment can be performed.Should clinical documentation become available, the clinical/medical investigation may be re-evaluated.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 50MM
• 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: 9681614
• MDR Text Key: 178146408
• Report Number: 3005975929-2020-00046
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502797
• UDI-Public: 03596010502797
• 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: 04/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 74121150
• Device Catalogue Number: OR74121150
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETLR CUP HAP 74120156/ UNKNOWN.; ACETLR CUP HAP 74120156/ UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention