MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S5-6RM/LL8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71422265
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/31/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed one year after original surgery and insert showed delamination.
Additional Manufacturer Narrative
The associated journey uni tibial insert was returned and evaluated.A lab analysis conducted during this investigation indicated that the articulating surface of the insert showed wear and deformation.There were no observations of material or manufacturing deviations in the course of this investigation.Our investigation including 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 clinical evaluation noted that based on the explant analysis and without pre and post-op imaging for comparison the root cause of the insert scratches, reported early delamination and intraoperative findings cannot be concluded.However, the ¿slight projection of the tibial plateus to the medial (approx.1 mm)¿ from the primary uni-implantation, the small osteophyte (which was removed during the revision), and/or possible 3rd body debris could have been contributing factors to the reported event.The patient impact beyond the wear, revision, and expected transient post-op convalescence period cannot be determined.No further investigation 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 S5-6RM/LL8MM
• 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: 8146232
• Report Number: 1020279-2018-02722
• Device Sequence Number: 1279686
• Product Code: HSX
• UDI-Device Identifier: 03596010582249
• UDI-Public: 03596010582249
• 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 Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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: No Information
• Device Expiration Date: 09/20/2026
• Device Catalogue Number: 71422265
• Device Lot Number: 16JM12003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 04/11/2019
• 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