MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS PAT RESRF RD 38 MM STD; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Catalog Number	74024838
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery had been performed, the patient developed an infection.The event was resolved by performing a revision surgery: the journey ii resurfaced patellar component was explanted.The patient outcome is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms responses to the requests for clinical documentation/information have not been received as of the date of this review; therefore the root cause of the reported infection and subsequent revision could not be fully assessed nor concluded.Per complaint details, the event was resolved by the revision.The patient impact beyond that which was reported could not be determined.No further assessment can be rendered at this time.Should clinically relevant documentation/information and/or product evaluation findings become available, the clinical/medical task may be re-evaluated.A review of complaint history for the listed part revealed no prior complaints for the following batch numbers.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.A review of risk management files and instructions for use found that the reported failure was documented appropriately.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.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.We consider this investigation closed.

• Brand Name: JRNY BCS PAT RESRF RD 38 MM STD
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10065232
• Report Number: 1020279-2020-01768
• Device Sequence Number: 574223
• Product Code: JWH
• UDI-Device Identifier: 03596010554550
• UDI-Public: 3596010554550
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

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 Catalogue Number: 74024838
• Device Lot Number: 19MM14015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 06/21/2021
• 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