MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP RT SZ 7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74021157
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a medical intervention was performed due to stiffness.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.A review of complaint history for the listed parts revealed no prior complaints for the listed failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.Our clinical/medical team concluded: no clinically relevant information has been provided for inclusion in this medical investigation. without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.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. no further actions are being taken at this time.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.A review of complaint history for the listed parts revealed no prior complaints for the listed failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.Our clinical/medical team concluded: no clinically relevant information has been provided for inclusion in this medical investigation.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.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.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: JRNY II CR FEM OX NP RT SZ 7
• 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: 7721440
• Report Number: 1020279-2018-01428
• Device Sequence Number: 1618600
• Product Code: JWH
• UDI-Device Identifier: 00885556422823
• UDI-Public: 00885556422823
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 74021157
• Device Lot Number: 16BM19361
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 07/09/2018; 07/09/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 10/05/2018; 10/29/2018
• 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: 59 YR