MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74027241
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Synovitis (2094)
Date of Event	08/01/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a revision surgery with synovitectomy on (b)(6) due to left knee synovitis.
Additional Manufacturer Narrative
Corrections based on new data received.
Event or Problem Description
During the revision surgery, articular insert was replaced while other components were left in situ.Intraoperatively it was noted thick synovitis, but the appearance of the tissue was not consistent with infection.As patient had a (b)(6) nasal swab, vancomycin was started in the pre op holding area.After the aspirate the patient was also given 2g of ancef iv.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see the attached file for the results of our investigation.(b)(4).

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6960803
• Report Number: 1020279-2017-00888
• Device Sequence Number: 19012477
• Product Code: JWH
• UDI-Device Identifier: 00885556170366
• UDI-Public: 00885556170366
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2017

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: 09/26/2021
• Device Catalogue Number: 74027241
• Device Lot Number: 11JM16052
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 10/31/2017; 10/31/2017
• Initial Report FDA Received Date: 10/19/2017
• Supplement Report FDA Received Date: 11/01/2017; 12/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JOURNEY TIBIA BASE NP LT SZ 3, 74022223/12MM01468; JRNY BCS PAT RESRF RD32MM STD,74024832/12KM06848; JRNYIIBCS XLPE ISRT SZ3-4LT9MM,74027241/11JM16052
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 82