MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP RT SZ 6; PROSTHESIS, KNEE, PATELLFMRTIBIAL, SMI-CNSTRIND, CMNTD, POLYMER/MTAL/POLYMER

Model Number	74021156
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to stiffness and pain from the customer.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that the x-rays provided do not indicate a reason for the stiffness.Without the device, rehab notes, operative reports, or relevant clinical information the root cause of the report stiffness and pain cannot be determined.We cannot rule out the buildup of scar tissue as a contributing factor.Per communications, the doctor believes this product was not defective but technical issues.The future impact to the patient beyond the revision cannot be determined.No further clinical/medical assessment is warranted at this time.Should any additional medical information be provided this complaint would be re-assessed.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Pain is a potential complication associated with any surgery.Some potential probable causes of this event could include patient reaction or a post-operative healing issue.

• Brand Name: JRNY II CR FEM OX NP RT SZ 6
• Common Device Name: PROSTHESIS, KNEE, PATELLFMRTIBIAL, SMI-CNSTRIND, CMNTD, POLYMER/MTAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9418518
• Report Number: 1020279-2019-04290
• Device Sequence Number: 2491493
• Product Code: JWH
• UDI-Device Identifier: 00885556422830
• UDI-Public: 00885556422830
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2020

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 Model Number: 74021156
• Device Catalogue Number: 74021156
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 03/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71420578 GII RF PT 35MM; 74022294 JII XR BP 4 RT; 74023830 JII XR IS 3-4 RT 8MM; 71420578 GII RF PT 35MM; 74022294 JII XR BP 4 RT; 74023830 JII XR IS 3-4 RT 8MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention