MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEM COCR LT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74024925
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a medical intervention was required to treat pain.
Additional Manufacturer Narrative
The associated devices were not returned as they remain implanted.Based on the available information the root cause of this patient¿s ¿pain¿ cannot be concluded.It is within the six month window generally accepted as post-operative recovery time.The patient¿s current status has not been provided at this time.Should any relevant information become available, this complaint can be re-assessed.A review of manufacturing records did not reveal any deviations that could have contributed to the reported issue.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.If additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JRNY BCS II FEM COCR LT SZ 5
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7206425
• Report Number: 1020279-2018-00060
• Device Sequence Number: 10992155
• Product Code: JWH
• UDI-Device Identifier: 00885556611432
• UDI-Public: 00885556611432
• Combination Product (Y/N): N
• 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: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2018

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: 74024925
• Device Lot Number: 01514080
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2017
• Supplement Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 05/21/2018
• 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: Required Intervention
• Patient Age: 72 YR