MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN REV TIBIA BASE SZ 7 LT; PRSTHSS,KN,PTLLFMRTBL,SEM-CNSTRND,CMNTD,PLYMR/MTL

Model Number	71424007
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery had to be performed due to prosthetic infection.The legion rev tibia base size 7 left was implanted on (b)(6) 2017 and explanted the same year on (b)(6) 2017.Initially, it was reported that the incident was from another manufacturer, the mistake came out and the report was changed with the correct manufacturer and the original details.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: LGN REV TIBIA BASE SZ 7 LT
• Common Device Name: PRSTHSS,KN,PTLLFMRTBL,SEM-CNSTRND,CMNTD,PLYMR/MTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 10012127
• Report Number: 1020279-2020-01399
• Device Sequence Number: 3303514
• Product Code: JWH
• UDI-Device Identifier: 03596010546111
• UDI-Public: 03596010546111
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2020

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: 11/13/2023
• Device Model Number: 71424007
• Device Catalogue Number: 71424007
• Device Lot Number: 13LM11747
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 12/29/2020
• 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: 71420551 LEGION INSERT, LOT 13DM19192.; 71421165 LGN OX FEM 5 LT, LOT 13BM03030.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 81 YR