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

Model Number	74021167
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/12/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after surgery, the patient presented arthrofibrosis of left knee.Manipulation under anesthesia was performed to resolve the issue.
Additional Manufacturer Narrative
It was reported that after surgery, the patient presented arthrofibrosis of left knee.Manipulation under anesthesia was performed to resolve the issue.The affected journey ii tibial inserts, journey cr oxinium femoral component, journey bcs resurfacing patellar component and journey ii xr tibial baseplate, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches 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.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.Possible causes could include but not limited to joint tightness or traumatic injury.Without the return of the actual product involved and no patient medical records, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: JRNY II CR FEM OX NP LT SZ 7
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9377893
• Report Number: 1020279-2019-04158
• Device Sequence Number: 3078271
• Product Code: JWH
• UDI-Device Identifier: 00885556422762
• UDI-Public: 00885556422762
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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: 12/19/2024
• Device Model Number: 74021167
• Device Catalogue Number: 74021167
• Device Lot Number: 14MM16318
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 01/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR