MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN JOURNEY II CR KNEE TIB INSERT; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 01/26/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, after a tka surgery was performed, the patient experienced pain, a dislocation, and pcl rupture.This adverse event was treated by a revision surgery on (b)(6) 2024, in which the insert was exchanged to a journey ii deepdish insert.The femoral component and tibial baseplate were remained.Patient's current health status is unknown.No more information is available.

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, in the absence of the requested medical documentation, clinical factors which could have contributed to the reported pain, a dislocation, and posterior cruciate ligament rupture could not be definitively concluded, and a causal relationship to the reported adverse events and the devices could not be confirmed nor concluded.According to the report, the patient was revised, and the insert was exchanged, however, the femoral component and tibial baseplate were retained.The impact to the patient beyond the reported pain, a dislocation, and posterior cruciate ligament rupture cannot be determined since the health status of the patient is unknown.Should any additional relevant medical information be provided, this case would be re-assessed.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.The devices' specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, risk management file and prior actions could not be performed.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include joint tightness, traumatic injury, patient condition, postoperative care, size selected or abnormal loading of limb.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.

• Brand Name: UNKNOWN JOURNEY II CR KNEE TIB INSERT
• 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: 18831288
• MDR Text Key: 336822499
• Report Number: 1020279-2024-00479
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male