MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 RT 13MM; PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL

Model Number	74027255
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported revision of journey ii bcs was performed due to the breakage of the insert¿s post.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 5-6 RT 13MM
• Common Device Name: PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9716276
• Report Number: 1020279-2020-00569
• Device Sequence Number: 367103
• Product Code: JWH
• UDI-Device Identifier: 00885556179567
• UDI-Public: 00885556179567
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020

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 Model Number: 74027255
• Device Catalogue Number: 74027255
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 11/26/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 12/10/2020
• 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