MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 1-2 RT 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 74027213

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 03/26/2024

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, after tka surgery had been performed on (b)(6) 2024, the patient experienced pain during rehabilitation.The x ray showed that the jrny ii bcs xlpe art isrt sz 1-2 rt 11mm was disassociated.This adverse event was solved by revision surgery on (b)(6) 2024, in which the insert was exchanged.The doctor thinks that this was due to inadequate insertion of the insert.It is unknown the current health status of patient.

Manufacturer Narrative

H3, h6: the reported event was analyzed.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the jrny ii bcs xlpe art isrt sz 1-2 rt 11mm.Therefore, no investigation is deemed for the other devices.The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that, according to the report, an unprovided x-ray revealed that the insert was disassociated.Approximately two weeks post-implantation, on (b)(6) 2024; the patient underwent a revision surgery wherein the insert was exchanged to treat this adverse event.No other information or imaging was provided for this review.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 previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that repeated assembly and disassembly of the modular components could compromise a critical locking action of the components.Surgical debris must be cleaned from components before assembly.Debris inhibits the proper fit and locking of modular components which may lead to early failure of the procedure.Modular components must be assembled securely to prevent disassociation.This has been identified as a warning and precaution.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 evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include inadequate insertion of the insert, size selected or abnormal loading of limb.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 BCS XLPE ART ISRT SZ 1-2 RT 11MM
• Type of Device: 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: 19116311
• MDR Text Key: 340282146
• Report Number: 1020279-2024-00755
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556178768
• UDI-Public: 00885556178768
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/14/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 74027213
• Device Lot Number: 23HM10042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 74022113/JRNY II BCS FEMORAL OXIN RT SZ 3; 74022212/JOURNEY TIBIA BASE NP RT SZ 2
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 56 KG