MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION TIB BASE W/JOURNEY LOCK SZ 2 L; PROSTHESIS,KNEE,PTELLOFMOROTIBL,SMI-CNSTRND,CMNTD,PLYMR/MTAL/PLYMR

Catalog Number	71933568
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to tibia loosening.It was replaced with another legion tibia base and 220mm long stem.
Additional Manufacturer Narrative
A review of complaint history did not reveal additional complaints for the listed device.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.The clinical medical investigation concluded that no relevant clinical medical information was provided to conduct a thorough medical assessment.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Proceed based on information provided/available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by j.Templeton, medical director.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: ¿patient information ¿surgical procedure/post-operative care review ¿device labeling (including technique guides, ifus, etc.) no relevant clinical medical information was provided to conduct a thorough medical assessment.

• Brand Name: LEGION TIB BASE W/JOURNEY LOCK SZ 2 L
• Common Device Name: PROSTHESIS,KNEE,PTELLOFMOROTIBL,SMI-CNSTRND,CMNTD,PLYMR/MTAL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8348137
• Report Number: 1020279-2019-00624
• Device Sequence Number: 16634004
• Product Code: JWH
• UDI-Device Identifier: 00885556061244
• UDI-Public: 00885556061244
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2019

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: 71933568
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 02/18/2019
• Supplement Report FDA Received Date: 06/16/2019
• 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: Other; Required Intervention