MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP LT SZ 7; PRSTHSIS,KNEE,PATLLFMROTIBIAL,SMI-CNSTRND,CMNTD, POLYMER/METAL/POLYMER

Catalog Number	74021167
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a manipulation under anesthesia due to arthrofibrosis.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.The devices were manufactured in 2016 and 2017.Our clinical analysis noted that based on the information provided, this adverse event is likely related to the stiffness and scaring that is often associated with this procedure and not due to a failure of the s&n device itself.Post mua, this patient went from 0-70 degrees to 125 degrees and remains in the study.Since there are no plans to do a revision, no further clinical/medical assessment is warranted at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: JRNY II CR FEM OX NP LT SZ 7
• Common Device Name: PRSTHSIS,KNEE,PATLLFMROTIBIAL,SMI-CNSTRND,CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7712360
• Report Number: 1020279-2018-01348
• Device Sequence Number: 19033914
• Product Code: JWH
• UDI-Device Identifier: 00885556422762
• UDI-Public: 00885556422762
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2018

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 Catalogue Number: 74021167
• Device Lot Number: 17LM18673
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2018
• Supplement Date Received by Manufacturer: 06/24/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 12/17/2018
• 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: Other; Required Intervention
• Patient Age: 46 YR