MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM COCR NP LT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 74021265

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

Patient Problems Loss of Range of Motion (2032); Fibrosis (3167)

Event Date 02/28/2024

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, after a cori assisted left tka surgery performed on (b)(6) 2023, the patient has experienced loss of range of motion and arthrofibrosis in the left knee.The patient is currently recovering after a manipulation under anesthesia performed on (b)(6) 2024.No other injuries were reported.

Manufacturer Narrative

H3, h6: although the involvement of the cori devices was reported, the relationship with the investigated failure was directly associated to the knee implants.Given the nature of the alleged incident, the implants could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the information provided, the reported arthrofibrosis is likely the result from the procedure itself and not the result of mal performance of the implant, instruments, or failure of implant and/or instrument.Arthrofibrosis is a known potential post-surgical occurrence.The arthrofibrosis cannot be ruled out as the likely cause of the reported loss of range of motion.Patient impact beyond the reported arthrofibrosis, loss of range of motion, and subsequent manipulation under anesthesia could not be determined.For the resurfacing patella, the provided product identification information did not match any known release of this part and thus a manufacturing record review could not be conducted.A review of the production orders for the rest of the implants did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the femoral component, tibial baseplate and insert, 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 resurfacing patella, the complaint history review revealed a similar event for the listed device over the previous 12 months; the batch number provided is not valid within the system, even though the review was performed and did not reveal similar events.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 that decreased range of motion has been identified in possible adverse effects section as a result of 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 level is still adequate.A historical review concluded that there are no prior actions related to this products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include alignment, size selected, wear, traumatic injury, joint tightness, patient condition 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.

• Brand Name: JRNY II CR FEM COCR NP LT SZ 5
• 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: 19029149
• MDR Text Key: 339209210
• Report Number: 1020279-2024-00661
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556615263
• UDI-Public: 00885556615263
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74021265
• Device Lot Number: B2218480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2022
• 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: JOURNEY TIBIA BASE NP LT SZ 4, LOT#:22BM04821; JRNY BCS PAT RESRF RD 32 MM STD, LOT#:22BM04821; JRNY II ISRT XLPE DD LT SZ 3-4 10MM, LOT#:23BM1116; REAL INTELLIGENCE CORI, SN:SN000013
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 66 KG