MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR KNEE IMPLANT SIZE 7L; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	71421237
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Pain (1994); Joint Disorder (2373)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient continued to have issues following a surgery and another procedure to remove scar tissue.Surgeon assessed the patient's left knee as having loose components and recommended surgery.The surgery is scheduled for (b)(6) 2017.
Additional Manufacturer Narrative
Please see the attached file for the results of our investigation.(b)(4).
Event or Problem Description
It was reported the patient continued to have issues following a surgery and another procedure to remove scar tissue.Surgeon assessed the patient¿s left knee as having loose components and recommended surgery.A two-step revision surgery was performed on (b)(6) 2010 (exploratory left knee tka, with removal of markedly loose legion femoral component and insert and placement of antibiotic spacers) and on (b)(6) 2010 (placement of new sn tka system).

• Brand Name: LGN CR KNEE IMPLANT SIZE 7L
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: robert rust ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 6720574
• Report Number: 1020279-2017-00533
• Device Sequence Number: 16409807
• Product Code: JWH
• UDI-Device Identifier: 00885556030486
• UDI-Public: 00885556030486
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/17/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71421237
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/14/2017
• Supplement Date Received by Manufacturer: 07/14/2017; 04/01/2025; 06/24/2025; 09/13/2025
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 11/08/2017; 04/16/2025; 07/08/2025; 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71453134/ASKU
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 121 KG