MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS NP FEM SZ 6 LT; PROSTHESIS, KNEE, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Model Number	71423226
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had s&n components since (b)(6) 2012.The knee was revised for loosening due to osteolysis and possible infection.All components were removed today and replaced with a cement spacer and a legion dished 5-6 13mm poly.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to osteolysis and possible infection.The patient had components implanted 8 years ago.The affected genesis ii high flexion insert, legion femoral component, genesis ii resurfacting patella and genesis ii tibial baseplate, used in treatment, were not returned for evaluation.Therefore, a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.The lot number for the patella was not provided.A review of the complaint history for the listed parts (except the patella) revealed no prior complaints for the listed failure mode with the same batch number.The devices were sterilized according to sterilization release documentation from quality control.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.Review of the risk management files identified the reported failure as potential adverse events.No medical documents were provided.Therefore no medical assessment can be performed at this time.Per ifu, osteolysis may occur around the prosthetic components as a consequence of foreign-body reaction to particulate wear debris.Particles are generated by interaction between components as well as between the components and bone, primarely through wear mechanisms of adhesion, abrasion and fatigue.

• Brand Name: LEGION PS NP FEM SZ 6 LT
• Common Device Name: PROSTHESIS, KNEE, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9699522
• Report Number: 1020279-2020-00520
• Device Sequence Number: 1877783
• Product Code: JWH
• UDI-Device Identifier: 03596010611413
• UDI-Public: 03596010611413
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2020

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: 03/13/2022
• Device Model Number: 71423226
• Device Catalogue Number: 71423226
• Device Lot Number: 12DM11572
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 06/29/2020
• 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: Required Intervention