MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM COCR NP RT SZ 7; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 74021257

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

Patient Problems Loss of Range of Motion (2032); Scar Tissue (2060); Fibrosis (3167); Swelling/ Edema (4577)

Event Date 07/22/2022

Event Type  Injury  

Event Description

It was reported that, after a tka was performed on (b)(6) 2022, the patient experienced issues with scar tissue growth, pain, and swelling which seems to be limiting his range of motion.In (b)(6) 2022 a knee manipulation was performed which actually reduced the knee range of motion even more.Over the last 9 months with orthoepic massage and physical therapy patient can extend his leg to 10 deg and flex it to 110 deg, with popping.Current health status patient is unknown.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6.The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, as of the date of this medical investigation, the supporting clinical documentation has not been provided; therefore, definitive clinical factors could not be concluded to have contributed to the reported event.However, scar tissue formation is a known post-surgical occurrence and is not indicative of a component malperformance.Patient impact beyond the reported post-tka symptoms, subsequent manipulation, and ongoing range of motion limitations with popping cannot be determined.No further medical assessment can be rendered at this time.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, instructions for use, risk management file and prior actions review could not be performed.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 traumatic injury, 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.

Manufacturer Narrative

H10.B7 and h6 (health effect - clinical code and health effect - impact code).

Event Description

It was reported that, after a visionaire assisted right tkr was performed on (b)(6) 2022, the patient experienced issues with scar tissue growth, pain, and swelling which seems to be limiting his range of motion.On (b)(6) 2022, a knee manipulation was performed which reduced the knee range of motion even more.Over the last 9 months with orthoepic massage and physical therapy patient can extend his leg to 10 deg and flex it to 110 deg, with popping.The patient kept suffering from persistent stiffness.On (b)(6) 2023, the main symptoms were loss of extension and abnormal gait.On (b)(6) 2023, the patient underwent a right knee arthroscopy with lysis of adhesions and a manipulation under anesthesia.The patient is making progress, but it¿s still very slow and limited.On 25-jul-2023 the patient indicated that over the last three (3) months there have not been any more improvements.

Manufacturer Narrative

H10.Additional information in a2, a3, a4, b7, d1, d2, d4, d10, g4 and h9.H11.Corrected information in b3 and b5.

Event Description

It was reported that, after a visionaire assisted right tkr was performed on (b)(6) 2022, the patient experienced issues with scar tissue growth, pain, and swelling which seems to be limiting his range of motion.On (b)(6) 2022, a knee manipulation was performed which reduced the knee range of motion even more.Over the last 9 months with orthoepic massage and physical therapy patient can extend his leg to 10 deg and flex it to 110 deg, with popping.The patient kept suffering from persistent stiffness.On (b)(6) 2023, the main symptoms were loss of extension and abnormal gait.On (b)(6) 2023, the patient underwent a right knee arthroscopy with lysis of adhesions and a manipulation under anesthesia.The patient is making progress, but it¿s still very slow and limited.On (b)(6) 2023 the patient indicated that over the last three (3) months there have not been any more improvements.On (b)(6) 2023 a iovera treatment was performed to help reduce the pain; however, the swelling, stiffness and deep pain continues.

Manufacturer Narrative

B5: describe event or problem.Section h3, h6: given the nature of the alleged incident the devices could not be returned for evaluation.The clinical/medical investigation concluded that, based on the documentation provided, the reported extensive arthrofibrosis contributed to the reported patient symptoms and is a known post-surgical occurrence not indicative of a component malperformance; however, it is unknown if the patient has a sensitivity or comorbidity that would possibly contribute to the severity and/or recurrence of the symptoms.Additionally, the possible baseplate medial overhang and noted mild valgus alignment cannot be ruled out as potential contributing factors.The patient impact included the reported symptoms, additional arthroscopy, two manipulation under anesthesia, cryoanalgesia therapy, physical therapy with massage, and reported persistent deep pain, swelling and range of motion limitations.Further patient impact could not be determined.No further medical assessment can be rendered 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 journey ii xr articular insert xlpe medial size 5-6 right 9mm a review of complaint history based on the historical data revealed a similar event for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.For the rest of the devices 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 systems revealed in the possible adverse effects section that decreased range of motion and 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 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 traumatic injury, patient condition, patient medical history and/or postoperative care.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.D4: catalog#.

• Brand Name: JRNY II CR FEM COCR NP RT SZ 7
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-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: 16620738
• MDR Text Key: 312286137
• Report Number: 1020279-2023-00670
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00885556615195
• UDI-Public: 00885556615195
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74021257
• Device Lot Number: B1710600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2017
• 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: 71926225 / 21KM14994.; 74023751 / 16FM16776.; 74023851 / 17MM06603.; 74023851 / 18CM21360.
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 89 KG