MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE LT SZ 1-2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74025621
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Limited Mobility Of The Implanted Joint (2671)
Date of Event	01/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in experiencing mid flexion instability and it was determined that the patient compromised the pcl.The patient had cr knee in there already and to correct the problem we put in a dished cr insert.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.A review of complaint history revealed no prior complaints for the listed lot.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, 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 ISRT XLPE LT SZ 1-2 9MM
• 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: 7190819
• Report Number: 1020279-2018-00045
• Device Sequence Number: 158492
• Product Code: JWH
• UDI-Device Identifier: 00885556422670
• UDI-Public: 00885556422670
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2018

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: No Information
• Device Catalogue Number: 74025621
• Device Lot Number: 12JM14882
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2018
• Supplement Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 01/15/2018
• Supplement Report FDA Received Date: 04/16/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention