MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS FEMORAL OXIN RT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74022114
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	12/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
Event or Problem Description
It was reported that, after a cori assisted right tka surgery had been performed on (b)(6) 2023, the patient experienced stiffness (limited range of motion).This adverse event was treated by knee manipulation under anesthesia on (b)(6) 2023.Current health status of patient is recovered.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the devices could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, as of this date supporting clinical documentation has not been provided, therefore, a clinical root cause for the reported stiffness, limited range of motion and subsequent manipulation under anesthesia cannot be confirmed.The patient impact was the manipulation under anesthesia and post operative convalescence period.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device 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 decreased range of motion 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 product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include alignment, size selected or wear.Based on this investigation, the need for corrective action is not indicated.Should 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 FEMORAL OXIN RT SZ 4
• 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: 18694342
• Report Number: 1020279-2024-00352
• Device Sequence Number: 15255319
• Product Code: JWH
• UDI-Device Identifier: 00885556169865
• UDI-Public: 00885556169865
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

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: 74022114
• Device Lot Number: 23HM09739
• 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: 01/23/2024
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 03/18/2024
• Date Device Manufactured: 08/16/2023
• 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: 74021342/JII AS XLPE ART ISRT SZ 3-4 RT 10MM.; 74022213/JOURNEY TIBIA BASE NP RT SZ 3.; 74027429/POROUS OVAL PATELLA SZ 29MM.; ROB10024/REAL INTELLIGENCE CORI.; ROB10100/CORI KNEE TENSIONER.; ROB10101/CORI KNEE TENSIONER CARTRIDGE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 65 KG