MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK FEM ASSEMBLY SZ 7 LT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71421377

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 05/07/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on the patient due to set screw backed out of the poly.There was a significant defect on medial aspect of femur so the decision was made to change the femur.No procedure details reported.

Manufacturer Narrative

The associated complaint devices were not returned.The clinical/medical team concluded, without the requested supporting clinical documents, a thorough medical investigation cannot be rendered.Should any clinical information become available this complaint can be re-assessed.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.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: LGN HK FEM ASSEMBLY SZ 7 LT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8651801
• MDR Text Key: 146423457
• Report Number: 1020279-2019-02090
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00885556414880
• UDI-Public: 00885556414880
• Combination Product (y/n): N
• PMA/PMN Number: K081111
• 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: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2021
• Device Catalogue Number: 71421377
• Device Lot Number: 14EAF0011A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention