MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE RT SZ 1-2 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74025614
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed due to dislocation.Retrieved insert showed that the medial side deformed (damaged).
Additional Manufacturer Narrative
The associated journey ii cr insert was returned and evaluated.From the lab analysis conducted during this investigation, it was concluded that the insert is fractured on the medial side.There are no scratches visible on the lateral side of the articulating surface, and only visible on the far medial side of the insert.The non-articulating surface of the insert also has scratches.The locking mechanism of the insert is intact with minimal deformation around the anterior insertion/extraction slot.The fractured area is grossly deformed with multiple fracture planes visible.No evidence of material or manufacturing deviations were observed in 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 complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A clinical evaluation noted that based on an analysis of the provided radiographic images the root cause of the dislocation most likely resulted from instability due to insufficient thickness of the inlay.It was reported that the revision was successfully completed with a thicker inlay.The future impact to the patient beyond the revision cannot be concluded.No further clinical/medical assessment is warranted at this time.No further medical assessment can be rendered at this time.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JRNY II CR ISRT XLPE RT SZ 1-2 12MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7716751
• Report Number: 1020279-2018-01394
• Device Sequence Number: 13701951
• Product Code: JWH
• UDI-Device Identifier: 00885556422717
• UDI-Public: 00885556422717
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2018

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: Lay User/Patient
• Device Catalogue Number: 74025614
• Device Lot Number: 14FM19047
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 12/26/2018
• 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
• Patient Weight: 60