MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS FEMORAL OXIN RT SZ 5; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER

Model Number	74022115
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Fibrosis (3167)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that after a tka surgery had been performed on (b)(6) 2022 with a journey ii and cori system, patient presented arthrofibrosis and post operative stiffness.Manipulation under anesthesia was scheduled for (b)(6) 2022.Adverse event has not been resolved.
Additional Manufacturer Narrative
A2: age or date of birth and d11: concomitant medical products and therapy dates.Section h3, h6: given the nature of the alleged incident, the devices, could not be returned for evaluation.The clinical/medical investigation concluded that, per complaint details, the study-patient experienced arthrofibrosis and post operative stiffness with pain post right cori assisted journey ii and was scheduled approximately 2 months post implantation for manipulation under anesthesia to treat the adverse event.The adverse event is unrelated to the cori robotic system/instruments, possibly related to the procedure, and is not resolved.The provided electronic case report forms do not provide insight into the reported symptoms.As of the date of this medical investigation, no further updates have been provided; therefore, definitive contributing clinical factors could not be concluded.Arthrofibrosis, however, is a known post-operative occurrence and does not corroborate a component malperformance.It was communicated that the patient¿s current health status is ¿not recovered¿ as the outcome is ¿pending update¿.The patient impact beyond the reported right knee arthrofibrosis/post operative stiffness and pain cannot be determined.No further medical assessment could be rendered at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed devices.A review of the instructions for use documents for knee systems revealed in warnings and precautions, postoperative section that use extreme care in patient handling is needed and postoperative patient care and directions and warnings to patients by physicians are extremely important.Patients should be directed to seek medical opinion before entering potentially adverse environments that could affect the performance of the implant.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to these products and event.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include patient condition or postoperative care.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.H6: health effect - clinical code and health effect - impact code.

• Brand Name: JRNY II BCS FEMORAL OXIN RT SZ 5
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16056449
• Report Number: 1020279-2022-05105
• Device Sequence Number: 14686599
• Product Code: JWH
• UDI-Device Identifier: 00885556169919
• UDI-Public: 00885556169919
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2023

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: 74022115
• Device Catalogue Number: 74022115
• Device Lot Number: 22CM02147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JOURNEY TIBIA BASE NP RT SZ 4, LOT#:22BM10426; JRNY BCS PAT RESRF RD 29 MM STD, LOT#:22AM17675; JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM, LOT#:22GM; REAL INTELLIGENCE CORI, SN: (B)(6)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female