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

Model Number	71422261
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during uni-tka surgery, the journey uni tibial insert s5-6lm/rl8mm could not be implanted.The surgeon made a change in surgical technique and used a bigger size insert to complete the procedure.It is unknown if there was a surgical delay.No injury to patient was reported.
Additional Manufacturer Narrative
Results of investigation: it was reported that during tka surgery, the journey uni tibial insert s5-6lm/rl8mm could not be implanted.The surgeon made a change in surgical technique and used a bigger size insert to complete the procedure.The affected complaint device, used in treatment, was returned and evaluated.A visual inspection of the returned device shows damage on the lock detail probably from the attempt of insertion.Dimensional analysis could not be performed as the damage/deformation at several features of the device would not allow for accurate measurement.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.Based on this investigation, the need for corrective action is not indicated.A clinical analysis noted all documents and images provided as of this date have been reviewed and consider and unless noted do not contribute to the clinical investigation.A review of risk management files found that the reported failure was documented appropriately.The instructions for use indicated in the warnings and precautions that it is extremely important to select the appropriate type and size with consideration of anatomical and biomechanical factors such as patient age and activity levels, weight, bone and muscle conditions.Potential causes of the reported event could include but are not limited to size of device used, surgical technique or procedural/user variance.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.We consider this investigation closed.

• Brand Name: JOURNEY UNI TIBINRT S5-6LM/RL8MM
• Common Device Name: PRSTHSS,KNEE,FMRTBIL,NON-CONSTRAINED,CMNTD,METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10367102
• Report Number: 1020279-2020-03685
• Device Sequence Number: 3358993
• Product Code: HSX
• UDI-Device Identifier: 03596010582201
• UDI-Public: 03596010582201
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71422261
• Device Catalogue Number: 71422261
• Device Lot Number: 19CM05491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Initial Date Received by Manufacturer: 07/11/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 10/23/2020
• 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: Required Intervention