MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS FEMORAL OXIN LT SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 74022123

Device Problems Failure to Osseointegrate (1863); Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 11/09/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, after a tka surgery was performed on (b)(6) 2022, the patient experienced loosening of one (1) jrny ii bcs femoral oxin lt sz 3, one (1) journey tibia base np lt sz 3, one (1) gns ii resurf pat 32mm and one (1) jrny ii bcs xlpe art isrt sz 3-4 lt 10mm.This event was treated by conducting a revision surgery on (b)(6) 2022.Patient's current health status is unknown.

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, no supporting clinical documentation has been provided.Reportedly, implant loosening necessitated the revision; however, definitive contributing clinical factors could not be concluded based on the limited information provided.The patient impact beyond the reported loosening and revision cannot be determined.No further medical assessment is warranted at this time.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.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 device.A review of the instructions for use documents for knee system 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 files revealed this failure mode was previously identified.The anticipated risk levels are 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 product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, size selected, lack of ingrowth, osteolysis and/or traumatic injury.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: JRNY II BCS FEMORAL OXIN LT SZ 3
• Type of Device: 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: 15923367
• MDR Text Key: 304874252
• Report Number: 1020279-2022-04894
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556170311
• UDI-Public: 00885556170311
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74022123
• Device Catalogue Number: 74022123
• Device Lot Number: 16FM02222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2016
• 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
• Treatment: GNS II RESURF PAT 32MM(PN:71420576, LN:14HM05702).; JRNY II INS SZ3-4 LT10MM(PN:74027242,LN:13EM11674).; JRNY TIBIA BASE LT SZ 3(PN:74022223, LN:18EM00660).
• Patient Outcome(s): Hospitalization; Required Intervention