MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4 LT 10MM; PRSTHSS,KN,PTLLFMRTBL, SM-CNSTRND,CMNTD,POL/METL/POL

Catalog Number	74027242
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	05/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after tka procedure, a revision surgery was performed due to suspected infection.No delay.The jrny ii bcs xlpe art isrt sz 3-4 lt 10mm was replaced using a s&n backup device.
Additional Manufacturer Narrative
Additional information received by the customer has identified that this event has been already reported under 1020279-2020-02716, case-(b)(4).The new information confirms that this is a duplicate complaint, therefore, if further details are provided in future confirming the opposite, our files will be updated accordingly and a further report will be submitted outlining both events details and our investigations performed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4 LT 10MM
• Common Device Name: PRSTHSS,KN,PTLLFMRTBL, SM-CNSTRND,CMNTD,POL/METL/POL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10117318
• Report Number: 1020279-2020-01979
• Device Sequence Number: 16606401
• Product Code: JWH
• UDI-Device Identifier: 00885556177662
• UDI-Public: 885556177662
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 08/26/2020

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 Catalogue Number: 74027242
• Device Lot Number: 19CM23381
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 08/26/2020
• 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: Required Intervention