MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS PAT BICONVEX 29 MM STD; PROSTHSIS,KNEE,PATELLOFEMOROTIBIAL,SMI-CONSTRAIND,CMNTD,POLYMR/MTAL/POLYMER

Catalog Number	74024629
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/29/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an irrigation and a debridement with polyethylene exchange in the left knee due to left knee arthrofibrosis and infection.The tibial insert component was removed.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Based on the available information, a root cause for "arthrofibrosis and possible infection" cannot be concluded.However, they are known complication of surgery.This is a retroactive study.The event occurred in 2015 and is now documented as resolved.No further harm to the patient is expected.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.This device was implanted prior to its expiration date.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: JRNY BCS PAT BICONVEX 29 MM STD
• Common Device Name: PROSTHSIS,KNEE,PATELLOFEMOROTIBIAL,SMI-CONSTRAIND,CMNTD,POLYMR/MTAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7017824
• Report Number: 1020279-2017-00999
• Device Sequence Number: 19157262
• Product Code: JWH
• UDI-Device Identifier: 03596010531018
• UDI-Public: 03596010531018
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

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: 07/28/2016
• Device Catalogue Number: 74024629
• Device Lot Number: 06GM15245
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 07/31/2018
• 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: 69 YR