MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY PFJ IMPLANT X-SM RT; PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71461011
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	08/23/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a right knee journey pfj was revised to a tka due to progression of disease.The patella was inspected and left in situ.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: JOURNEY PFJ IMPLANT X-SM RT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6863319
• Report Number: 1020279-2017-00743
• Device Sequence Number: 16362008
• Product Code: KRR
• UDI-Device Identifier: 03596010573315
• UDI-Public: 03596010573315
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K051086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2017

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: 04/21/2017
• Device Catalogue Number: 71461011
• Device Lot Number: 07DM17667
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 09/13/2017
• Supplement Report FDA Received Date: 12/04/2017
• 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
• Patient Age: 58 YR