MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S5-6LM/RL9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71422262
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 presented with infection status post total knee arthroplasty.
Additional Manufacturer Narrative
The associated journey uni tibial baseplate, journey uni tibial insert and journey uni femoral component were not returned for evaluation.Therefore visual inspection could not be performed.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 complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.Products were sterilized according to sterilization release documentation from quality control.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A clinical analysis noted that no clinical documents were provided.Therefore, no thorough clinical assessment of the reported issue can be rendered at this time.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.Without the return of the actual product involved nor medical records available, our investigation of this report is inconclusive.Should additional information be received, the complaint will be reopened for investigation.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JOURNEY UNI TIBINRT S5-6LM/RL9MM
• 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: 8489977
• Report Number: 1020279-2019-01417
• Device Sequence Number: 13869194
• Product Code: HSX
• UDI-Device Identifier: 03596010582218
• UDI-Public: 03596010582218
• 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: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2019

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: 71422262
• Device Lot Number: 17HM13131
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/07/2019
• Supplement Report FDA Received Date: 04/27/2019
• 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