MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY II UNI TIBIA BASEPLATE SIZE 2 RM/LL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71935200
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to tibial plateau necrosis.
Additional Manufacturer Narrative
Additional info: d4, d10, g7, g9, h2, h3, h4, h6, h10.Results of investigation: it was reported that a revision surgery was performed due to tibial plateau necrosis.The associated journey ii uni tibial base plate, used in treatment, was not returned for evaluation.Therefore, the product analysis could not be performed.The review of manufacturing records was conducted and it did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part 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.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.The revision operative notes submitted with the adverse event forms were reviewed and unless noted do not contribute to the clinical investigation.Per the documents received, the issue was resolved with a revision to a total knee.No further medical assessment is performed at this time.A review of risk assessment revealed the post-operative issue is previously identified in the possible adverse events.Possible causes could include but not limited to patient medical history, age of patient or traumatic injury.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.
Additional Manufacturer Narrative
Additional info d11.

• Brand Name: JOURNEY II UNI TIBIA BASEPLATE SIZE 2 RM/LL
• 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: 9137567
• Report Number: 1020279-2019-03513
• Device Sequence Number: 1825099
• Product Code: HSX
• UDI-Device Identifier: 00885556578797
• UDI-Public: 00885556578797
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K152315
• 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,Followup
• Report Date (Section B): 03/31/2020

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 Model Number: 71935200
• Device Catalogue Number: 71935200
• Device Lot Number: 18EAP0094A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 09/05/2019; 09/05/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 03/31/2020; 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART:71422352/ OXINIUM FEMORAL/LOT: 17MM07411; PART:71935218/JOURNEY II INSERT/LOT: 17GAP7860D
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention