MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR BASEPLATE SZ 2 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74021163
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference: case (b)(4).
Event or Problem Description
It was reported that, after a tka had been performed on (b)(6) 2018, the patient experienced an anterior cruciate ligament rupture.A revision surgery was performed on (b)(6) 2023 to address this adverse event.Patient's outcome is pending.
Event or Problem Description
It was reported that, after a left tka had been performed on (b)(6) 2018, the patient experienced an anterior cruciate ligament rupture.A revision surgery was performed on (b)(6) 2023 to address this adverse event on which the tibial component was replaced.Patient's outcome is pending.
Additional Manufacturer Narrative
B5 (event description), d1, d4 (product information), g4 (510k), h4 (manufacturing date).
Additional Manufacturer Narrative
H3, h6.The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, the study-patient required a left total knee arthroplasty revision due to an anterior cruciate ligament rupture after almost 4.5 years post implantation, captured under adverse event.The provided electronic case report form notes the start date as 28-mar-2023 and the event involving the primary study region was reportedly ongoing as of 29-mar-2023.The electronic case report form operative page was reviewed; however, did not provide insight into a clinical root cause of the reported event.It was communicated that the date of the anterior cruciate ligament rupture and the patient current status is unknown.As of the date of this medical investigation, no further supporting clinical documentation has been provided.Based on the limited information provided, a definitive clinical root cause of the reported event cannot be confirmed nor concluded.The patient impact beyond the reported ruptured anterior cruciate ligament and subsequent tibial baseplate/insert revision intervention could not be determined; however, the adverse event was reportedly ongoing.Therefore, should additional documentation become available in the future, the clinical/medical evaluation may be re-evaluated.No further medical assessment could be rendered 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 knee systems revealed that postoperative patient care and directions and warnings to patients by physicians are extremely important.Protected weight bearing with external support is recommended for a period of time to allow healing.Normal daily activity may be resumed at the physician¿s direction.Use extreme care in patient handling.Postoperative therapy should be structured to prevent excessive loading of the operative knee, this has been identified as a postoperative patient care and warnings.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury and/or patient condition.Based on this investigation, the need for corrective action is not indicated.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 2 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: 16732358
• Report Number: 1020279-2023-00813
• Device Sequence Number: 6843775
• Product Code: JWH
• UDI-Device Identifier: 00885556615324
• UDI-Public: 00885556615324
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K152726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2023

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: 74021163
• Device Catalogue Number: 74022202
• Device Lot Number: 16MSL0001A
• 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: 03/30/2023
• Supplement Date Received by Manufacturer: 03/30/2023; 05/19/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 04/19/2023; 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2017
• 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: PN: 71421032 / LOT: 18KM13677.; PN: 74022202 / LOT: 16MSL0001A.; PN: 74023721 / LOT: 17JM03146.; PN: 74023821 / LOT: 17JM11569.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female