MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S3-4LM/RL9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71422252
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/07/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to fracture of the knee joint.
Additional Manufacturer Narrative
Results of investigation: it was reported that a revision surgery was performed due to fracture of the knee joint.The associated journey ii uni tibial insert, journey ii uni tibial baseplate and deuce femoral component, used in treatment, were not returned for evaluation.Therefore the product analysis could not be performed.As device details were not made available, the device history record review cannot be completed.There is no information that would suggest the devices failed to meet specifications.A relationship, if any, between the devices and the reported incident could not be corroborated.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Our investigation noted that the related base plate and the femoral component have been obsolete at this time.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.A review of instructions of use and 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
Updated results of investigation: it was reported that a revision surgery was performed due to fracture of the knee joint.The associated journey ii uni tibial insert, journey ii uni tibial base plate and deuce femoral component, used in treatment, were not returned for evaluation.Therefore the product analysis could not be performed.As device details were not made available, the device history record review cannot be completed.There is no information that would suggest the devices failed to meet specifications.A relationship, if any, between the devices and the reported incident could not be corroborated.All efforts to obtain additional information regarding this complaint did not provide any results.Only one letter from the patient¿s representative has been received with incomplete and contradictory information.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Our investigation noted that the related base plate and the femoral component have been discontinued and are no longer available on the market.Health care facility st.-antonius stift emsteck does not exist anymore since 2013 and no medical documents were received for investigation.Therefore no medical assessment can be performed at this time.A review of instructions of use and risk assessment revealed the post-operative issue is previously identified in the possible adverse events.Possible causes could include but are not limited to traumatic injury, size of device used or overuse.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 additional information be received, the complaint will be reopened.

• Brand Name: JOURNEY UNI TIBINRT S3-4LM/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: 9394681
• Report Number: 1020279-2019-04201
• Device Sequence Number: 11511450
• Product Code: HSX
• UDI-Device Identifier: 03596010582133
• UDI-Public: 03596010582133
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/17/2021

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: 71422252
• Device Catalogue Number: 71422252
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 11/08/2019; 11/08/2019; 08/17/2021
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 03/18/2020; 07/08/2020; 08/17/2021
• 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: DEUCE FEM OXZR SZ 4 LT 71422204, UNK LOT; JOURNEY UNI TIBIAL BASE 71422224 , UNK LOT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 90