MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP LT SZ 5; PROST, KNEE, PATFEMTIB, SEMI-CNSTRIND, CMENTD, P/M/P

Model Number 74021165

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

Patient Problems Bacterial Infection (1735); Loss of Range of Motion (2032); Joint Contracture (4528)

Event Date 07/25/2022

Event Type  Injury  

Event Description

It was reported that, 6 weeks after a tka with a journey ii cr knee system, on (b)(6) 2022, patient experienced a flexion and extension contracture, rom 82/20/20.Patient was hospitalized for a manipulation under anesthesia of the knee on (b)(6) 2022 and went uneventful.Patient started rehabilitation right after and is still recovering.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: given the nature of the alleged incident, the device was not returned for evaluation.A x-ray photo was provided, but a clinical evaluation could not determine the reason for the reported contracture.The clinical/medical investigation concluded that, based on the information provided, the definitive clinical root cause of the reported flexion contracture could not be determined.Although we cannot rule out the patient¿s age, immobility, trauma, rehabilitation/physical therapy performance, or medication (mirtazapine), as likely contributory factors.Per the report, the patient¿s range of motion was reported as 82/20/20, prior to the manipulation under anesthesia.The manipulation under anesthesia report was not provided; however, it was reported everything went according to the study protocol.The impact to the patient beyond the reported adverse event and the manipulation under anesthesia cannot be determined since it was reported the patient started rehabilitation right after and is still recovering.Therefore, no further clinical/medical assessment is warranted at this time.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 revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed as a possible adverse effect that flexion contracture 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 product specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, rehabilitation plan non-compliance or patient condition.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should 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.Internal complaint reference number: (b)(4).

Event Description

It was reported that, after a tka surgery with a journey ii cr knee system was performed on (b)(6) 2022, on (b)(6) 2022, patient experienced a flexion and extension contracture, rom 82/20/20.In order to treat this event, patient was hospitalized for a manipulation under anesthesia of the knee on (b)(6) 2022 and went uneventful.Patient started rehabilitation, within 2 months a recurrent stiffness occurred.On (b)(6) 2023 the flexion and extension contracture persisted, therefore, an arthroscopic release was performed with six tissue samples for culture analysis.Surgery went uneventful, the post operative rom was 120/15/15.The tissue samples for cultures taken during surgery on turned out positive for bacteria.This confirms the diagnosis: low-grade pji and it is the most probable cause for the ongoing arthrofibrosis.Further options for treatment of pji will be discussed with the patient (amongst others, a two-stage revision).

Manufacturer Narrative

H10: additional information in b5.H11: corrected information in h6.(health effect - clinical code and health effect - impact code).

Manufacturer Narrative

Additional information: h4 (manufacturing date), h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: given the nature of the alleged incident, the devices, could not be returned for evaluation.The clinical/medical investigation concluded that, based on the information provided, the culture and tissue samples obtained during the arthroscopic release were positive for bacteria confirms the diagnosis of low grade prosthetic joint infection.Per report, the prosthetic joint infection cannot be ruled out as a cause of the ongoing arthrofibrosis.It was reported, further options for treatment of the prosthetic joint infection (amongst others, a two-stage revision) will be discussed with the patient.Consequently, the impact to the patient beyond that which has already been reported cannot be determined since additional treatment options are being discussed.Therefore, no further clinical/medical assessment is warranted at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the femoral and insert components, a review of complaint history revealed a similar event for the listed devices over the previous 12 months, but no similar events for the batches based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.For the tibial baseplate and patella, 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 instructions for use documents for knee systems revealed in possible adverse effects that flexion contracture 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.Also infection has been identified in possible adverse effects.A review of the risk management files 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 these products and event.A review of the sterilization records revealed the batches were sterilized within normal parameters.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, patient anatomy, patient condition and/or medical history.Based on this investigation, the need for corrective action is not indicated.Should 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 CR FEM OX NP LT SZ 5
• Type of Device: PROST, KNEE, PATFEMTIB, SEMI-CNSTRIND, CMENTD, P/M/P
• 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: 15540383
• MDR Text Key: 301151909
• Report Number: 1020279-2022-04315
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556422786
• UDI-Public: 00885556422786
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74021165
• Device Catalogue Number: 74021165
• Device Lot Number: 22BM00216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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: 71421032 / RESURFACING PAT / 22BM17793; 74022223 / JOURNEY TIBIA BASE / 21BM01417; 74025641 / JRNY II CR ISRT / 20KM16059
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 82 KG