MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE RT SZ 5-6 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTD, POLY/MET/POLY

Model Number	74021157
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/06/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Study: journey ii cr retro, subject id: scs-0078, ae#: 1.It was reported that patient presented a right knee incision infection.Event was resolved with the prescription of antibiotics and a with a revision surgery for a poly liner exchange.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical concluded that this clinical study reports an infection of the incision post-tka.Per clinical study documentation, the event was resolved as of 2017.The contra-lateral surgical date was provided; however, does not provide insight into the reported right knee infection/complaint, and there are no x-rays or operative reports provided.Therefore, based on the limited information provided, no further assessment can be rendered at this time.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.A review of sterilization documents indicated that the product was sterilized according to sterilization release documentation.Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.G1 mdr reporting contact name and address.

• Brand Name: JRNY II CR ISRT XLPE RT SZ 5-6 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTD, POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10662643
• Report Number: 1020279-2020-05331
• Device Sequence Number: 3551597
• Product Code: JWH
• UDI-Device Identifier: 00885556422823
• UDI-Public: 00885556422823
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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: 09/18/2025
• Device Model Number: 74021157
• Device Catalogue Number: 74025651
• Device Lot Number: 15JM14028
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 06/26/2021
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 06/28/2021
• 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: FEMORAL COMP (B)(4), LOT 15JM12534; TIBIAL COMP (B)(4), LOT 16EM20063
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention