MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE RT SZ 3-4 9MM; PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,POL/MET

Model Number	74025631
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/10/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a orthopedic surgery had to be performed due to arthrofibrosis on the right knee.Rehabilitation therapy following the tka with journey ii cr tks was performed on (b)(6) 2016.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this complaint from the united states and the journey ii cr clinical study, reports the knee was revised secondary to ¿arthrofibrosis of the right knee¿.The clinical study report form were submitted but did not reveal a root cause for the ¿arthrofibrosis¿.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Smith and nephew has not received the device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.Based on this investigation, the need for corrective action is not indicated.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.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this complaint from the united states and the journey ii cr clinical study, reports the knee was revised secondary to ¿arthrofibrosis of the right knee¿.The clinical study report form were submitted but did not reveal a root cause for the ¿arthrofibrosis¿.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Smith and nephew has not received the device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.Based on this investigation, the need for corrective action is not indicated.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 RT SZ 3-4 9MM
• Common Device Name: PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,POL/MET
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10141408
• Report Number: 1020279-2020-02321
• Device Sequence Number: 3220760
• Product Code: JWH
• UDI-Device Identifier: 00885556422601
• UDI-Public: 00885556422601
• 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): 06/19/2021

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: 08/28/2025
• Device Model Number: 74025631
• Device Catalogue Number: 74021163
• Device Lot Number: 15HM21659
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 06/16/2021; 06/16/2021
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 06/19/2021; 06/19/2021
• 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: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 111