MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION TIB BASE W/JOURNEY LOCK SZ 4 L; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71933570
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/17/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a total knee revision surgery due to aseptic loosening of left total knee arthroplasty.Patient developed increasing pain, and became intolerable.Loosening of device (tibial baseplate) shown on bone scan.The femur was well fixed , but because of a desire to lower the joint line and improve the situation, the femoral component was removed.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see the attached file for the results of our investigation.(b)(4).

• Brand Name: LEGION TIB BASE W/JOURNEY LOCK SZ 4 L
• 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: 6957327
• Report Number: 1020279-2017-00881
• Device Sequence Number: 13639628
• Product Code: JWH
• UDI-Device Identifier: 00885556062128
• UDI-Public: 00885556062128
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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: 10/25/2019
• Device Catalogue Number: 71933570
• Device Lot Number: 09KM14129
• 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: 10/18/2017
• Supplement Report FDA Received Date: 11/30/2017
• 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: JRNY BCS II FEMORAL OXIN LT SZ6,74022126/13BM11596; JRNY BCS PAT RESRF RD 35MM STD,74024835/13AM08204; JRNYIIBCS XLPE ISRT SZ3-4LT18MM,74027247/11JM09908; LGN OFFSET COUPLER 4MM, 71424225/13KSM0245B; LGN PRESSFIT STEM 14MMX160MM,71424047/13HAB0010C; SCR FULL STEP 3-4 10MM, 71423058/13JM18991
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 195