MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS CNSTRD ART ISRT 5-6 LT 15M; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 74029266

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094); Joint Laxity (4526)

Event Date 12/12/2023

Event Type  Injury  

Event Description

It was reported that, after a first tka revision surgery was performed, the patient experienced pain and instability.This adverse event was treated by a revision surgery on (b)(6) 2023, in which a jrny ii bcs cnstrd art isrt 5-6 lt 15m was exchanged to a 15mm bcs.Upon opening the knee it was noticed that the resurfacing patella had an indentation most likely to be result of contact with the post of the constrained poly.It was performed a complete synovectomy, some additional hereotopic bone was also removed.Knee and baseplate was well fixed.Pathology showed no active infection.The initial range of motion was very good and there was no patella/post contact at max flexion.Patient's current health status is unknown.

Manufacturer Narrative

Internal complaint number: (b)(4).

Manufacturer Narrative

Additional information: g2 (medwatch report number added) corrected data: e4 (initial reporter also sent report to fda?),.

Manufacturer Narrative

G3: report source: section h3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.However, the clinical/medical investigation concluded that the provided x-ray dated on (b)(6) 2023 appears to show bilateral total knee arthroplasty with scattered heterotopic bone formation (predominantly around the tibial baseplates) with the left insert appearing thicker than the right.Based on the limited documentation provided, definitive clinical factors cannot be concluded; however, muscle and/or tissue laxity cannot be ruled out as a potential contributing factor to the reported instability, which along with the heterotopic bone formation, could have contributed to the reported pain and the noted ¿indentation¿ on the resurfaced patella.The resurfacing patella is not visible and a root cause of the noted indention on the patella cannot be concluded.A component mal-performance cannot be concluded either.The current patient status is unknown.The patient impact included the reported pain, instability, possible impingement, and the revision procedure.Further patient impact could not be determined.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.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 in the warnings and precautions that correct selection of the implant is extremely important.The appropriate type and size should be selected for patients with consideration of anatomical and biomechanical factors such as patient age and activity levels, weight, bone and muscle conditions, etc.Failure to use the optimum size component may result in loosening, bending, cracking, or fracture of the component and/or bone.Additionally, the possible adverse effects section revealed that 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 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 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 size selected, muscle/joint laxity, heterotopic bone formation, patient condition or postoperative care.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.E1: initial reporter name and address, h6: health effect - clinical code.

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation revealed that pathology/cultures showed no active infection but findings consistent with poly debris.Patient provided an assessment which indicates a bilateral inflammatory reaction with suspected mechanical loosening as the cause for pain and swelling without any concern for infection.The provided anteroposterior x-ray appears to show bilateral total knee arthroplasties with scattered heterotopic bone formation (predominantly around the tibial baseplates) with possible bilateral radiolucency at inferolateral tibial baseplates and the left insert appears thicker than the right.The resurfacing patella is not visible and a root cause of the ¿indention¿ on the patella cannot be concluded.However, a 2nd revision surgical note dated 12/dec/2023 reveals ¿well-fixed¿ components in the presence of extensive heterotopic ossification and large bone spurs (removed).The surgeon suspects the choice of the constrained insert may have contributed to ¿some degree of wear¿.Stimulus of synovitis and the patient¿s pain complex as well as sense of instability¿ and the noted ¿post impinged both on the patella in deep flexion as well as on the femoral component and extension¿ most likely contributed to the reported pain, swelling and instability for which the 2nd left total knee arthroplasty revision was performed.Additionally, the noted heterotopic bone formation, bone spurs and scar tissue could have contributed to the reported pain, impingement and resultant ¿indentation¿ of the resurfaced patella; however, this cannot be confirmed.A component malperformance cannot be concluded.The current patient status is unknown.The patient impact included the reported pain and instability with ¿some degree of wear¿ and synovitis with the constrained insert, as well as the noted patella/femoral impingement, formation of heterotopic ossification and scar tissue with subsequent revision.The insert's batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.For the tibial baseplate and femoral component, 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 risk management files revealed this failure mode was previously identified.A review of previous actions concluded that there is a higher than expected risk of revision surgery when the patella is unresurfaced at the index surgery.Patella resurfacing is an intraoperative discretionary decision of the surgeon, and this clinical decision may mitigate risk for individual patients.Actions were taken to update the instructions for use document and surgical technique to include statements informing users that outcome data reported in some registries suggest that resurfacing the patella during primary total knee arthroplasty should be considered since it may decrease the rate of revision, provided the patient¿s anatomical and clinical conditions allow.The review of the instructions for use documents for knee systems also revealed in the warnings and precautions section states that correct selection of the implant is extremely important.The appropriate type and size should be selected for patients with consideration of anatomical and biomechanical factors such as patient age and activity levels, weight, bone and muscle conditions, etc.Failure to use the optimum size component may result in loosening, bending, cracking, or fracture of the component and/or bone.Moreover, the possible adverse effects section revealed that 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.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.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.

Event Description

It was reported that, after a first tka revision surgery had been performed to replace the original 11mm poly to a 15mm constraint poly, the patient experienced pain and instability.There was a significant v/v laxity when examined pre-op.This adverse event was treated by a revision surgery on (b)(6) 2023 to exchange the jrny ii bcs cnstrd art isrt 5-6 lt 15mm.Upon opening the knee, it was noticed that the resurfacing patella had an indentation most likely to be result of contact with the post of the constrained poly.It was performed a complete synovectomy, some additional heterotopic bone was also removed.Femur and baseplate were well fixed.Pathology showed no active infection.The initial range of motion was very good and there was no patella/post contact at max flexion.Patient's current health status is unknown.

• Brand Name: JRNY II BCS CNSTRD ART ISRT 5-6 LT 15M
• 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: 18461333
• MDR Text Key: 332252666
• Report Number: 1020279-2024-00029
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556176665
• UDI-Public: 00885556176665
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74029266
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• 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
• Treatment: 74022126/18HM14590/JRNY II BCS FEMORAL OXIN LT SZ.; 74022226/18LM00920/JOURNEY TIBIA BASE NP LT SZ 6.
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male