MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 10MM; PRSTHSIS,KNEE,PATLLFMORTIBIL,SMICONSTRAIND,CMNTD,POLYMER/METAL/POLYMER

Catalog Number	74027232
Health Effect - Clinical Codes	Fibrosis (3167); No Code Available (3191)
Date of Event	01/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a manipulation under anesthesia was performed due to knee arthrofibrosis and stiffness with cortisone injection into the right knee.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, no relevant supporting clinical information has been provided to assist with a clinical investigation, and there is no report of the patient's current condition.Therefore based on insufficient information, a clinical assessment cannot be performed at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.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 II BCS XLPE ART ISRT SZ 3-4-RT 10MM
• Common Device Name: PRSTHSIS,KNEE,PATLLFMORTIBIL,SMICONSTRAIND,CMNTD,POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis, tennessee; memphis 38116
• MDR Report Key: 7949440
• Report Number: 1020279-2018-02123
• Device Sequence Number: 1311633
• Product Code: JWH
• UDI-Device Identifier: 00885556179062
• UDI-Public: 00885556179062
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2019

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: 06/27/2025
• Device Catalogue Number: 74027232
• Device Lot Number: 15FM23105
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 04/03/2019
• 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