MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	74027271
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	11/05/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had right lower extremity edema with excessive wound drainage, right femoral deep vein thrombosis with ecchymosis about right thigh.Event was resolved with medication.
Additional Manufacturer Narrative
Correction: date received by manufacturer.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and no relevant clinical information has been provided to perform a thorough medical investigation.However, the associated failure mode of dvt has been identified in the ifu as a possible adverse effect#9 since this issue was reported as resolved, no further clinical/medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, 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 BCS XLPE ART ISRT SZ 7-8 RT 9MM
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8928690
• Report Number: 1020279-2019-03150
• Device Sequence Number: 10823642
• Product Code: JWH
• UDI-Device Identifier: 00885556179710
• UDI-Public: 00885556179710
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K11711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2019

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 Expiration Date: 04/27/2026
• Device Catalogue Number: 74027271
• Device Lot Number: 16DM22039
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 07/25/2019; 12/04/2019
• Initial Report FDA Received Date: 08/24/2019
• Supplement Report FDA Received Date: 08/26/2019; 12/09/2019
• 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: Required Intervention