MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS PAT RESRF RD 35 MM STD; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number	74024835
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Swelling (2091); Injury (2348)
Date of Event	12/05/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had chronic knee swelling that results in a surgical intervention: bursectomy.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached file for our results of investigation.
Additional Manufacturer Narrative
The 510k associated with concomitant devices: k111711.
Event or Problem Description
Additional information received indicates the patient developed a pre patellar effusion which was larger and did not diminish with time or compression.Therefore a bursectomy was performed.

• Brand Name: JRNY BCS PAT RESRF RD 35 MM STD
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6829616
• Report Number: 1020279-2017-00674
• Device Sequence Number: 19005758
• Product Code: JWH
• UDI-Device Identifier: 00885556169919
• UDI-Public: 00885556169919
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2018

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: 02/07/2022
• Device Catalogue Number: 74024835
• Device Lot Number: 12BM07463
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 08/02/2017; 08/02/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 02/16/2018; 02/26/2018
• 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 RT SZ 5, (B)(4); JRNY BCS PAT RESRF RD 35 MM STD, (B)(4); JRNY II BCS XLPE ART ISRT SZ 5-6 RT 12MM, (B)(4)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 82