MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74027234
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery surgeon tried to implant insert, but the insert would not sit into the tibial tray.S&n backup available.No surgical delay or injury to patient reported due this event.
Additional Manufacturer Narrative
H11: the manufacturer has identified that this event should be re-evaluated for mdr reporting.The re-assessment determined that the issue does not meet the threshold for reporting and is a non-reportable event, as this malfunction has not caused or contributed, in the past, to death or serious injury, and it does not have the potential to do so if it was to recur.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4-RT 12MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10877365
• Report Number: 1020279-2020-06592
• Device Sequence Number: 3803160
• Product Code: JWH
• UDI-Device Identifier: 00885556179161
• UDI-Public: 00885556179161
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74027234
• Device Catalogue Number: 74027234
• Device Lot Number: 18BM17484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2020
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1