MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II UNI OX FEMORAL 9 LM/RL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	74026029
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Insufficient Information (4580)
Date of Event	09/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a ukr had been performed on (b)(6) 2022 an unspecified adverse event occurred that led to the system removal on (b)(6) 2022.It was an engage system used with journey uni oxinium femoral component.It is unknown what the current health status is.
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that based on the limited information provided, we are unable to conclude what lead to the fracture that likely lead to the revision.According to the journey ii ifu review, use of the journey femoral component with the engage system could be considered off-label use as the unicompartmental knee system is designed as a system and does not allow the substitution of components from other systems or manufacturers unless specially approved.It cannot be concluded that the revision was associated with a mal-performance of the implant or implant failure.The patient impact beyond the revision cannot be determined.No further clinical assessment is warranted at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for journey ii in section device description revealed that journey ii uni femoral components are not compatible with engage system.It also states that each unicompartmental knee system is designed as a system and does not allow the substitution of components from other systems or manufacturers unless specially approved by the manufacturer of the components.A review of the risk management file 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 this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique used or user/procedural variance.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that based on the limited information provided, we are unable to conclude what lead to the fracture that likely lead to the revision.According to the journey ii instructions for use review, use of the journey femoral component with the engage system could be considered off-label use as the unicompartmental knee system is designed as a system and does not allow the substitution of components from other systems or manufacturers unless specially approved.It cannot be concluded that the revision was associated with a mal-performance of the implant or implant failure.The patient impact beyond the revision cannot be determined.No further clinical assessment is warranted at this time.A review of the production records 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 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 journey ii in section device description revealed that journey ii uni femoral components are not compatible with engage system.It also states that each unicompartmental knee system is designed as a system and does not allow the substitution of components from other systems or manufacturers unless specially approved by the manufacturer of the components.A review of the instructions for use documents for engage partial knee system revealed in the warnings and precautions that under no circumstances should an engage partial knee component be used in combination with a component from another manufacturer.There is not enough data available to conclude that the overall clinical benefit outweighs the potential risk profile when compared to the state of the art.The existing data identifies a potential signal that the performance is an outlier vs the state of the art with respect to the risk for revision.In addition, a historical review concluded that no previous escalated actions for this type of issue were identified.However, as a correction action a voluntary market removal will be performed for the engage cementless partial knee system due recent complaint data that indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique used or user/procedural variance.Based on this investigation, the need for corrective action may be indicated.
Event or Problem Description
It was reported that, after a ukr had been performed on (b)(6) 2022, an unspecified adverse event occurred that led to the system removal on (b)(6) 2022.A fracture was mentioned, but it was not clarified if this was referring to patient's bone or to a prosthesis component.It is important to note that an engage system was used with journey uni oxinium femoral component.It is unknown what the current health status is.

• Brand Name: JRNY II UNI OX FEMORAL 9 LM/RL
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 15656521
• Report Number: 1020279-2022-04519
• Device Sequence Number: 16720154
• Product Code: HSX
• UDI-Device Identifier: 00885556675823
• UDI-Public: 00885556675823
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K190085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2023

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: 74026029
• Device Catalogue Number: 74026029
• Device Lot Number: 21DM14374
• 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: 09/28/2022
• Supplement Date Received by Manufacturer: 11/17/2022; 07/06/2023
• Initial Report FDA Received Date: 10/23/2022
• Supplement Report FDA Received Date: 11/21/2022; 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• 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: 1-10011-300/TIBIAL ANCHOR STEM SIZE 5-6; 1-10012-600/POROUS TIBIAL TRAY SIZE 6-LEFT MEDIAL; 1-10013-610/TIBIAL INSERT SIZE 6-LEFT MED 10MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Unknown
• Patient Weight: 96 KG