MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR BASEPLATE SZ 3 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74022203
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, after a tka surgery had been performed in (b)(6) 2019 with a journey ii xr system, patient experienced loosening in their left knee.A revision surgery was performed to explant the jrny ii xr baseplate sz 3 lt along with the insert to resolve the reported event.
Additional Manufacturer Narrative
The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that based on the information provided in the case records forms, the root cause of the reported event(s) could not be definitively concluded and the patient impact beyond the reported loosening, revision, and termination of study participation cannot be determined.No further medical assessment could be rendered at this time.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 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 risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the instructions for use for this device revealed that loosening, bending, cracking, or fracture of implant components can occur as a result of trauma, strenuous activity, improper alignment,or duration of service.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 and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.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
The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a left tka revision was performed approximately 2.5 years post implantation due to ¿loosening¿.The adverse event complaint record form (crf) documents the serious adverse event as unrelated to the study device and/or procedure; however, the adverse event medical board was unable to exclude that the study device had contributed to the reported issue with a start date of 25-jun-2020 and stop date/recovered/resolved of (b)(6) 2020 with termination of participation in the study after revision/replacement of tibial component with ¿cs¿ (which has not been clarified as of the time of this medical investigation; therefore it is unknown if this refers to a cement spacer).The crf showed zone 14 tibial baseplate with 1mm radiolucency at the 3 month follow-up with increasing radiolucency and additional zones at the 6 month checkup.Of note in the crf, the implant disposition shows the tibial base and insert were ¿removed¿/explanted, while the femoral and patellar components were retained.Based on the information provided in the crfs, the root cause of the reported event(s) could not be definitively concluded and the patient impact beyond the reported loosening, revision, and termination of study participation cannot be determined.No further medical assessment could be rendered at this time.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 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 knee systems revealed that loosening, bending, cracking, or fracture of implant components can occur as a result of trauma, strenuous activity, improper alignment,or duration of service.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 and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.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.

• Brand Name: JRNY II XR BASEPLATE SZ 3 LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 14655074
• Report Number: 1020279-2022-02868
• Device Sequence Number: 14840497
• Product Code: JWH
• UDI-Device Identifier: 00885556615331
• UDI-Public: 00885556615331
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74022203
• Device Catalogue Number: 74022203
• Device Lot Number: 18ESL0008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 07/08/2022; 07/29/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 07/11/2022; 08/03/2022
• Date Device Manufactured: 07/24/2018
• 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: JRNY II XR INS XLPE MED 3-4 LT 8MM, LOT#:17LM18849.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown