MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4 LT 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74027243
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Fibrosis (3167)
Date of Event	12/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tkr surgery performed on (b)(6) 2022, the patient's post operative range of motion was 0-110 degrees.The surgeon indicated that after this the patient was non-compliant with physio and developed a fixed flexion deformity of approximately 7-10 degrees.The surgeon performed several manipulations under anesthesia, after which it was possible to straighten the patient's leg and regain a range a of motion of 0-110 degrees.Nevertheless, the patient was still non-compliant and developed a fixed flexion deformity again of 7-10 degrees.The surgeon then decided to perform a revision surgery on (b)(6) 2023 to solve this issue.The tibial 11mm insert was removed and downsized to a new 9mm insert.The surgeon noticed that the patient had significant scar tissue, which could have caused the fixed flexion deformity.The surgeon was able to achieve 0-110 degrees range of motion.Patient's current health status is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Additional Manufacturer Narrative
H10: h3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that, as of the date of this medical investigation, no supporting medical documentation had been provided; therefore, definitive contributing clinical factors cannot be concluded.The instructions for use possible adverse effects notes that decreased range of motion can result from improper implant selection.However, scar tissue formation is a known potential post-surgical occurrence and does not support a component malperformance.The current patient status is unknown.Patient impact beyond the reported insert revision/downsizing from an 11mm to a 9mm thickness after several manipulations due to a fixed flexion deformity along with the ¿significant scar tissue¿ finding cannot be determined.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 extreme care in patient handling is needed and 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.Patients should be directed to seek medical opinion before entering potentially adverse environments that could affect the performance of the implant.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 improper implant selection, patient non-compliance and/or patient medical history.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 3-4 LT 11MM
• 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: 18479813
• Report Number: 1020279-2024-00061
• Device Sequence Number: 6775365
• Product Code: JWH
• UDI-Device Identifier: 00885556177716
• UDI-Public: 00885556177716
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2024

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: 74027243
• Device Lot Number: 21HM15709
• 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: Not provided
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• 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: GEN II RSRF PAT29MM(PN:71421029,LN:21AB01132); JRNY II BCS FM OX LT SZ4(PN:74022124,LN:15FM06665); JRNY TIB BS LT SZ3(PN:74022223,LN:21GM02555)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown