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	01/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to remove an implant.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, no relevant clinical medical information was provided to conduct a thorough medical assessment.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.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: 8326056
• Report Number: 1020279-2019-00506
• Device Sequence Number: 1774696
• 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
• 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): 05/08/2019

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: 01/17/2019
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 05/08/2019
• 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
• Patient Age: 76 YR