MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR BASEPLATE SZ 3 LT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74022203
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to tibia pain.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The medical investigation concluded that the details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.Based on the limited information provided the root cause of the reported pain cannot be determined.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: JRNY II XR BASEPLATE SZ 3 LT
• 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: 8958209
• Report Number: 1020279-2019-03252
• Device Sequence Number: 2099361
• Product Code: JWH
• UDI-Device Identifier: 00885556615331
• UDI-Public: 00885556615331
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2019

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: 74022203
• Device Lot Number: 18ASL0003C
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 11/25/2019
• 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: PART NUMBER 74023740/ LOT NUMBER 16BM09318; PART NUMBER 74023840/ LOT NUMBER 16LM12244
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention