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 Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant was revised due to disease progression, not implant failure.No more information available.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, no clinical supporting documents were provided to conduct a thorough assessment of the reported issue.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.No further actions are being taken at this time.We consider this investigation closed.

• 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: 8429570
• Report Number: 1020279-2019-01084
• Device Sequence Number: 199061
• Product Code: KRR
• UDI-Device Identifier: 03596010573315
• UDI-Public: 03596010573315
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051086
• 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): 06/20/2019

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: 71461011
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 06/20/2019
• 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