MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE LT SZ 3-4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74025633
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed because the left insert was implanted into a right knee.
Additional Manufacturer Narrative
The associated complaint device was not returned.Based on the information provide, the root cause of the reported issue is the result of a potential user/procedural related error.No clinical documents were provided, therefore, no thorough clinical assessment of the reported issue can be rendered.A review of the complaint history revealed no previous complaints with the same failure mode for the listed part.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: JRNY II CR ISRT XLPE LT SZ 3-4 9MM
• 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: 8034064
• Report Number: 1020279-2018-02352
• Device Sequence Number: 16469573
• Product Code: JWH
• UDI-Device Identifier: 00885556422588
• UDI-Public: 00885556422588
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2019

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: 74025633
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 10/17/2018; 10/17/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 11/19/2018; 05/15/2019
• 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