MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OX CONSTRAINED FEM 7 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71421167
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	05/10/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a revision surgery due to due to instability.Femoral component and tibial insert of total knee arthroplasty were revised.
Additional Manufacturer Narrative
Based on additional clarification from the field.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.[(b)(4)].

• Brand Name: LGN OX CONSTRAINED FEM 7 LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7044462
• Report Number: 1020279-2017-01062
• Device Sequence Number: 11225522
• Product Code: JWH
• UDI-Device Identifier: 03596010543868
• UDI-Public: 03596010543868
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/21/2018

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 71421167
• Device Lot Number: 16FM01940
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2017
• Supplement Date Received by Manufacturer: 11/10/2017; 01/24/2018; 01/24/2018
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 11/21/2017; 01/31/2018; 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GII CR DEEPFLEX ISRT S5-6 9MM,71421542/15MM07315
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR