MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP RT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74021154
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery was performed on (b)(6) 2023, the patient experienced pain and patella (bone) dislocation.Patella(bone) tracking disorder was already noted at the time of the primary surgery.It is possible that it was related to the installation of the primary implants.This adverse event was treated by a revision surgery on (b)(6) 2023, in which a jrny ii cr fem ox np rt sz 4, journey tibia base np rt sz 3 and jrny ii cr isrt xlpe rt sz 3-4 11mm were exchanged to competitor products.Patient's current health status is unknown.No more information is available.
Additional 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, based on the information provided, the root cause of the reported adverse event was likely related to not resurfacing the patella at the time of the implantation of the primary implants as recommended in the instructions for use for knee systems.The report stated that all products including the patella were replaced with competitor's products.The impact to the patient beyond the reported pain, patella dislocation, and the subsequent revision cannot be confirmed since the health status of the patient is unknown.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the tibial baseplate, a review of complaint history revealed similar events 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.For the insert and femoral component, the complaint history review for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events.A review of the instructions for use documents for knee systems provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.Additionally, the description of system section revealed 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.Smith & nephew describes patella resurfacing steps in the surgical technique guide and makes available implants and instruments to perform this surgical step.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 not resurfacing the patella at index surgery, traumatic injury, patient condition, postoperative care, size selected or abnormal loading of limb.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.H6: medical device problem code.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tka surgery was performed on (b)(6) 2023, the patient experienced pain and patella dislocation.Patella tracking disorder was noted from the primary surgery.This adverse event was treated by a revision surgery on (b)(6) 2023, in which a jrny ii cr fem ox np rt sz 4, journey tibia base np rt sz 3 and jrny ii cr isrt xlpe rt sz 3-4 11mm were exchanged to competitor products.Patient's current health status is unknown.

• Brand Name: JRNY II CR FEM OX NP RT SZ 4
• Common Device Name: 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: 18527132
• Report Number: 1020279-2024-00145
• Device Sequence Number: 20450439
• Product Code: JWH
• UDI-Device Identifier: 00885556422854
• UDI-Public: 00885556422854
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 74021154
• Device Lot Number: 23HM16331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2023
• Supplement Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 02/21/2024
• Date Device Manufactured: 08/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JOURNEY TIBIA BASE NP RT SZ 3; JRNY II CR ISRT XLPE RT SZ 3-4 11MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown