MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II ISRT XLPE DD RT SZ 3-4 9MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLY/METAL/POLY

Catalog Number	74025731
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Joint Swelling (2356)
Date of Event	11/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient who was diagnosed with cancer after his hip replacement, started swelling after his 4th dose of chemo and got inflamed.The dr did a debridement and synovectomy, changed the poly, and placed antibiotics into the wound before closing up again.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical analysis indicated that per communication, the revision/poly exchange with debridement and synovectomy was performed due to complications secondary to chemotherapy (swelling/inflammation).It was reported that the explant was sent to the hospital lab for testing.The patient impact beyond the symptoms reportedly secondary to chemotherapy, the revision/poly exchange procedure and a brief post-op rehabilitation period cannot be determined; however it was reported that the patient was doing well.No further 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.A review of complaint history on the listed part revealed no other complaints for the listed part.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.Should additional information be received, the complaint will be reopened.

• Brand Name: JRNY II ISRT XLPE DD RT SZ 3-4 9MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8128359
• Report Number: 1020279-2018-02670
• Device Sequence Number: 13895679
• Product Code: JWH
• UDI-Device Identifier: 00885556097212
• UDI-Public: 00885556097212
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K113482
• 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
• Report Date (Section B): 04/03/2019

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: 74025731
• Device Lot Number: 17LM20509
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 04/03/2019
• 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