MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S5-6RM/LL9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71422266
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 5 months after knee replacement, a revision surgery was performed due to unspecified reasons.
Additional Manufacturer Narrative
The affected journey uni tibial insert, oxinium component and journey uni tibial baseplate were not returned for evaluation.Therefore a thorough product analysis could not be performed.After repeated requests, smith and nephew has been unable to obtain device details and the reason for revision.As device details were not made available, device history record review cannot be completed.Complaint history review could not be performed with any accuracy due to lack of product information.Smith and nephew has an outstanding request with the reporter for information.Without the return of the actual product involved and no batch information available, our investigation of this report is inconclusive.Our clinical analysis noted no clinical relevant documents were provided to conduct a thorough medical assessment.No medical assessment is warranted at this time.The impact to the patient beyond the revision cannot be determined at this time.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.

• Brand Name: JOURNEY UNI TIBINRT S5-6RM/LL9MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8362175
• Report Number: 1020279-2019-00748
• Device Sequence Number: 2034697
• Product Code: HSX
• UDI-Device Identifier: 03596010582256
• UDI-Public: 03596010582256
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019

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: 71422266
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 05/21/2019
• 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