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	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that a revision surgery was performed due to loosening of the tibial implant.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to loosening of the tibial implant.The associated journey uni tibia insert, journey uni oxinium femoral component and journey uni tibial baseplate were removed but not returned for evaluation.Thus a product evaluation could not be performed.However, device details were provided.Thus, the review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts 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 products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Without the return of the actual product involved and no patient records provided, our investigation of this report is inconclusive.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.

• 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: 8765809
• Report Number: 1020279-2019-02616
• Device Sequence Number: 1679806
• Product Code: HSX
• UDI-Device Identifier: 03596010582218
• UDI-Public: 03596010582218
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K061011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2019

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: 16EM04893
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/06/2019
• Supplement Report FDA Received Date: 10/29/2019
• 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