MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number	74022123
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	01/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a revision surgery left medial meniscus surgery after a peri-prosthetic fracture around internal prosthetic left knee joint was discovered.
Event or Problem Description
It was reported that the patient did not undergo a revision surgery but was administered an unknown medication.The construct was in acceptable position/alignment.No evidence of loosening or loss of fixation; patella is tracking well.
Additional Manufacturer Narrative
Please see attached for the investigation results.
Additional Manufacturer Narrative
Additional information received, identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

• Brand Name: JRNY BCS II FEMORAL OXIN LT SZ 3
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6622572
• Report Number: 1020279-2017-00402
• Device Sequence Number: 808553
• Product Code: JWH
• UDI-Device Identifier: 00885556170311
• UDI-Public: 00885556170311
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• 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,Followup,Followup,Followup
• Report Date (Section B): 05/29/2018

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: 08/01/2026
• Device Catalogue Number: 74022123
• Device Lot Number: 16HM02835
• Initial Date Received by Manufacturer: 05/11/2017
• Supplement Date Received by Manufacturer: Not provided; 05/11/2017; 05/11/2017; 05/11/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 06/14/2017; 09/29/2017; 05/23/2018; 05/29/2018
• 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
• Patient Age: 63 YR
• Patient Weight: 68