MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S5-6RM/LL8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71422265

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 10/24/2023

Event Type  Injury  

Event Description

It was reported that after a tka surgery that was performed on (b)(6) 2023, one (1) journey uni tibinrt s5-6rm/ll8mm had dislocated.Patient was brought back to theatre for a liner exchange which was completed successfully.Patient returned to theatre again with another poly dislocation so was revised to tka on (b)(6) 2023.Health status of the patient is unknown.

Manufacturer Narrative

Internal complaint reference case (b)(4).

Manufacturer Narrative

Section h10: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, no relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Should any additional clinical information be provided, this complaint will be re-evaluated.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 in possible adverse effects that dislocation and subluxation 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 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 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, patient anatomy, postoperative care 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.Note: the first revision was reported under your reference number: 1020279-2023-02228 (our reference number: (b)(4)).Internal complaint reference number: (b)(4).

• Brand Name: JOURNEY UNI TIBINRT S5-6RM/LL8MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 18171003
• MDR Text Key: 328544916
• Report Number: 1020279-2023-02272
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010582249
• UDI-Public: 03596010582249
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K061011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71422265
• Device Lot Number: 19EM09969
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention