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

Model Number	71422261
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the journey uni tibial insert sz 5-6 lm/rl 8mm is luxated when placed into the knee.The surgeon always fixes the inlay on the tibial plateau before implantation, it was fixed firmly and is luxated under load.It was not reported if/how the problem was resolved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that the journey uni tibial insert sz 5-6 lm/rl 8mm is luxated when placed into the knee.The surgeon always fixes the inlay on the tibial plateau before implantation, it was fixed firmly and is luxated under load.The problem was fixed through revision and change of the insert on (b)(6) 2020.Initial surgery was performed on (b)(6) 2015.
Additional Manufacturer Narrative
H10: additional information in d7.H11: corrected information in b1, b2, b5 and h1.
Additional Manufacturer Narrative
Results of investigation: it was reported that a journey uni insert dislocated when the patient went down on his knees.The primary surgery was done in (b)(6) 2015 and the revision was performed in (b)(6) 2020.The affected complaint device, used in treatment, was not returned for evaluation and it has been communicated that device is in patient's possession.Therefore a product analysis could not be performed.A review of the manufacturing records for the listed batch 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 could not be corroborated.No medical documents were received for investigation.Therefore, no medical assessment can be performed at this time.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.It was reported that the patient regularly performs kneeling work.Some potential causes of the reported event could include but are not limited to traumatic injury or overuse.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew 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.
Event or Problem Description
It was reported that the journey uni tibial insert sz 5-6 lm/rl 8mm luxated when the patient went down on his knees.The surgeon always fixes the inlay to the tibial plateau before implantation, it was fixed firmly and it luxated under load.It has been communicated that the patient is a roofer and regularly performs kneeling work.The explanted insert is in patient's possession and further information will not become available.

• 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 rd.; memphis TN 38116
• MDR Report Key: 10217809
• Report Number: 1020279-2020-02857
• Device Sequence Number: 11404315
• 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
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2025
• Device Model Number: 71422261
• Device Catalogue Number: 71422261
• Device Lot Number: 15BM11910
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 09/24/2020; 12/16/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 09/24/2020; 01/08/2021
• 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