MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 15MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL

Catalog Number	71453214
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient fell following a manipulation and fractured her tibial tubercle in (b)(6) 2017.This was managed non operatively in a splint for 3 months.The fracture displaced.The fracture was placed with 2 screws and tension band wiring.Once fracture healed the stiffness continued.A revision surgery was performed to downsize the poly and release of soft tissue was performed.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please review attached for investigation results.(b)(4).

• Brand Name: LGN PS HIGH FLEX XLPE SZ 3-4 15MM
• 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: 6955445
• Report Number: 1020279-2017-00874
• Device Sequence Number: 19197586
• Product Code: JWH
• UDI-Device Identifier: 00885556035108
• UDI-Public: 00885556035108
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071071
• 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
• Report Date (Section B): 12/18/2017

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: 12/11/2025
• Device Catalogue Number: 71453214
• Device Lot Number: 15MM09531
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention