MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP LT SZ 7; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74022227
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that dr.Performed a left knee replacement on his patient on the (b)(6) 2018.She complained of persistent pain and stiffness and dr.Diagnosed her with severe arthrofibrosis.He took her back to theatre on (b)(6) 2019 and revised the femoral component to one size smaller and exchanged the insert.No more information shown.
Additional Manufacturer Narrative
Additional information received by the customer has identified that this event has been already reported under 1020279-2019-00512.The new information confirms that this is a duplicate complaint, therefore, if further details are provided in future confirming the opposite, our files will be updated accordingly and a further report will be submitted outlining both events details and our investigations performed.

• Brand Name: JOURNEY TIBIA BASE NP LT SZ 7
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8326958
• Report Number: 1020279-2019-00513
• Device Sequence Number: 2229356
• Product Code: JWH
• UDI-Device Identifier: 03596010554406
• UDI-Public: 03596010554406
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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: 74022227
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 06/13/2019
• 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: Hospitalization; Required Intervention