MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 LT 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74027261
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Dr revised a cocr journey ii bcs femur to an oxinium legion revision femur with coupler and stem.Patient was stiff (only 50 degrees range of motion) and had a lot of pain.Dr had already manipulated the knee once (date unknown).
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical medical investigation concluded that the single x-ray provided does not indicate a root cause to the reported joint stiffness.However, without the requested clinical information, pre/post primary x-rays, operative report, mua report and the explant, the root cause of the report pain cannot be concluded.The further impact to the patient beyond the revision and the expectation post-rehab and pain cannot be concluded.No further clinical medical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 5-6 LT 9MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8460193
• Report Number: 1020279-2019-01236
• Device Sequence Number: 16888502
• Product Code: JWH
• UDI-Device Identifier: 00885556177969
• UDI-Public: 00885556177969
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

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 Catalogue Number: 74027261
• Device Lot Number: 17LM20564
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 10/17/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 67 YR