MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VERSABOND AB 40 GRAMS F2; BONE CEMENT

Catalog Number 71271440

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Joint Swelling (2356)

Event Date 09/26/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to failure of the device.Swelling was reported.

Manufacturer Narrative

The associated complaint devices were not returned.The clinical/medical team concluded, based on the clinical documentation of noted edema tracks on the mri and an x-ray showing an 8mm foreign body in the medial soft tissues of mid-left thigh approximately 1 week prior to the noted tibial tray loosening, currently unable to rule out a possible injury as a precursor and contributing factor to the tibial component loosening.The patient impact beyond the reported pain, the revision surgery (all components due to competitor revision implants), and an expected brief post-operative rehabilitative phase cannot be concluded.No further medical assessment can be rendered at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches/failure mode.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.Credit cannot be issued for the devices.

• Brand Name: VERSABOND AB 40 GRAMS F2
• Type of Device: BONE CEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7924873
• MDR Text Key: 122293059
• Report Number: 1020279-2018-01957
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 03596010507372
• UDI-Public: 03596010507372
• Combination Product (y/n): N
• PMA/PMN Number: K022688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2014
• Device Catalogue Number: 71271440
• Device Lot Number: 11JC07300
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 10/01/2018
• Supplement Dates Manufacturer Received: 09/05/2018
• Supplement Dates FDA Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention