MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY UNI TIBIAL BASE LM/RL SZ 2; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71422422

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Inadequate Osseointegration (2646)

Event Date 05/25/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a tka performed on (b)(6) 2014, the jrny ni tibial base lm/rl sz 2 loosened and then collapsed.A revision surgery was performed on (b)(6) 2023 where the surgeon converted this patient's knee to a primary tka.The patient left surgery in good health, but current health status is unknown.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The photographs were reviewed, and revealed cement residue and blood, however, there are no visible defects that can be associated with the reported adverse event.The clinical/medical investigation concluded that, based on the limited information provided, the clinical root cause of the reported ¿uni tibia baseplate loosened and collapsed¿ cannot be definitively concluded.The patient impact is the uni tibia baseplate loosening/collapse and subsequent revision with explantation of the uni components and conversion to a primary total knee arthroplasty.Per a case communication, the patient left surgery in good health.¿ the patient¿s current health status remains unknown.Therefore, no further medical assessment can be rendered.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.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 looseness of components has been identified in possible adverse effects section as a 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 abnormal motion over time, bone degeneration, inadequate integration between the cement and bone/implant, and/or traumatic injury.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 UNI TIBIAL BASE LM/RL SZ 2
• 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: 17086756
• MDR Text Key: 316872553
• Report Number: 1020279-2023-01250
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556087893
• UDI-Public: 00885556087893
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71422422
• Device Catalogue Number: 71422422
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Sex: Female