MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 LT 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74027264
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperextension (4523); Joint Laxity (4526)
Date of Event	01/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: case-2024-00191274-1.
Event or Problem Description
It was reported that, after a tka had been performed on (b)(6) 2020, the patient experienced back knee and loosed knee tension.This adverse event was addressed by revision surgery on (b)(6) 2024, in which the jrny ii bcs xlpe art isrt sz 5-6 lt 12mm was exchanged to journey ii bcs insert 18mm.The other implants remained in patient.The surgeon did not think the products failed.Patient's current health status is unknown.
Additional Manufacturer Narrative
The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, without supporting clinical documentation, we are unable to conclude whether the loose knee tension was a result from a of a procedure 4 years prior or if an external event led to the back knee and loosed knee tension.Although, we cannot rule out ligament laxity, implant selection, or a history of trauma as likely contributing factors.It is unknown if the instructions for use for knee systems was adhered to.Since it has been reported, the current health of the patient is unknown, the impact to the patient beyond the reported loosening, the subsequent revision, and the expected post-operative convalescent period cannot be confirmed nor concluded.Furthermore, it cannot be concluded that this was a mal performance of the implant or an implant failure.Therefore, no further medical assessment can be rendered at this time.The devices' batch numbers were not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed devices.A review of the instructions for use documents for knee systems revealed in possible adverse effects that excessive rotation and unusual stress concentrations can result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.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 evidence to conclude that the products failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should the devices 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.
Event or Problem Description
It was reported that, after a tka had been performed on (b)(6) 2020, the patient experienced knee hyperextension and loosed knee tension.This adverse event was addressed by revision surgery on (b)(6) 2024, in which the jrny ii bcs xlpe art isrt sz 5-6 lt 12mm was exchanged to journey ii bcs insert 18mm.The other implants remained in patient.The surgeon did not think the products failed.Patient's current health status is unknown.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 5-6 LT 12MM
• 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: 18670694
• Report Number: 1020279-2024-00314
• Device Sequence Number: 18158480
• Product Code: JWH
• UDI-Device Identifier: 00885556178119
• UDI-Public: 00885556178119
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2024

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 Catalogue Number: 74027264
• Device Lot Number: UNKNOWN
• 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: 01/19/2024
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 71932636, LOT: UNKNOWN; PN:74022125 , LOT: UNKNOWN; PN:74022225 , LOT: UNKNOWN
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown