MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 5-6 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71453121
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to pain.
Additional Manufacturer Narrative
The associated genesis ii oxinium femoral component, legion cr high flexion insert and genesis ii cmt tibial baseplate were returned and evaluated.The patella component is not returned.A lab analysis conducted during this investigation revealed that the returned components showed inconsistent scratches on all devices.The femoral component has scratches on all surfaces and some bone cement still adhered to the bone contacting surface.The insert has scratches on both articulating and non-articulating surfaces and deformation of the locking mechanism.The tibial baseplate is scratched on the proximal surface as well as on the locking mechanism.The distal surface of the baseplate has scratches that are likely due to removal.Our investigation including a review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A clinical evaluation noted that without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LGN CR HIGH FLEX XLPE SZ 5-6 9MM
• 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: 7724626
• Report Number: 1020279-2018-01439
• Device Sequence Number: 1451679
• Product Code: JWH
• UDI-Device Identifier: 00885556033982
• UDI-Public: 00885556033982
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2018

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 Catalogue Number: 71453121
• Device Lot Number: 15JM14921
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 12/04/2018
• 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
• Patient Age: 44 YR