MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S5-6LM/RL8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71422261
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered from a postoperative infection.The customer requirement is to check the lot regarding sterility.No more information presented.
Additional Manufacturer Narrative
The associated journey uni tibial insert, journey uni cocr femoral component and journey uni tibial baseplate were not returned for evaluation.Our clinical analysis noted that no lab results or reports were provided to confirm the reported infection.Therefore a thorough medical assessment cannot be completed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Products were sterilized according to sterilization release documentation from quality control.There is no information that would suggest the implanted devices failed to meet specifications.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.Without the return of the actual products involved, our investigation of this report is inconclusive.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 S5-6LM/RL8MM
• 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: 8504461
• Report Number: 1020279-2019-01500
• Device Sequence Number: 222682
• Product Code: HSX
• UDI-Device Identifier: 03596010582201
• UDI-Public: 03596010582201
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2019

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: 71422261
• Device Lot Number: 18EM14142
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 03/18/2019; 03/18/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 07/31/2019; 07/31/2019
• 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