MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP LT SZ 7; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLY/METAL/POLY

Catalog Number	74021167
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Injury (2348)
Date of Event	12/29/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had persistent heartburn/chest pain for weeks prior to hospitalization, he believed this was due to gerd.He was then admitted to the hospital and required stent and bypass after cardiac testing.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.No cardiac markers or labs have been submitted either.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported stiffness and myocardial infarction cannot be determined.Root cause of the arthrofibrosis could be contributed to concomitant medical problems, rehabilitation, and history (bilateral hip replacement, bilateral knee meniscus repair, bilateral knee osteoarthritis, hypertension, mi) patient impact: arthrofibrosis and mua myocardial infarction treated with bypass and stent placement procedure with a hospital stay both incidents are listed as having been resolved.No further medical assessment is warranted based on the information provided.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 CR FEM OX NP LT SZ 7
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8725628
• Report Number: 1020279-2019-02415
• Device Sequence Number: 19279600
• Product Code: JWH
• UDI-Device Identifier: 00885556422762
• UDI-Public: 00885556422762
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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: 74021167
• Device Lot Number: 17AM13734
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 06/23/2019
• Supplement Report FDA Received Date: 11/05/2019
• 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; Other; Required Intervention
• Patient Age: 69 YR