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

Model Number	74021164
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, following a tka surgery on (b)(6) 2020, the patient has experienced falls.The patient appeared to be doing well until a few months ago.A revision surgery was performed on (b)(6) 2023 in order to treat this adverse event, in which a jrny ii cr fem ox np lt sz 4 was exchanged.The patient's current health status is unknown.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.A visual inspection of the returned femur size 4 reveals severe wear on the surface of the explant.The visual reveals a large piece of the device missing and dried bone cement on the device.A visual inspection of the returned insert reveals a large piece of the explant missing, discoloration and signs of severe wear.A review of complaint history for the part numbers over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.The clinical/medical evaluation concluded that based on the limited information provided, the definitive clinical root cause of the reported adverse event cannot be determined.Of note, the patient sustained several falls that cannot be ruled out as a precipitating factor the reported adverse event.Therefore, it cannot be concluded the reported events were associated with a mal performance of the implant or implant failure.Since it was reported the patient¿s health status is unknown, the patient impact beyond the reported falls and the subsequent revision cannot be confirmed nor concluded.Should any additional relevant medical information be provided, this case would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 product and event.A review of instructions for use for knee systems revealed in warnings and precautions, the patient should be warned of surgical risks, and made aware of possible adverse effects.The patient should be warned that the device does not replace normal healthy bone, and that the implant can break or become damaged as a result of strenuous activity or trauma, and has a finite expected service life and may need to be replaced in the future.Factors that could contribute to the reported event include friction, joint tightness, patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JRNY II CR FEM OX NP LT 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: 17295251
• Report Number: 1020279-2023-01427
• Device Sequence Number: 4070411
• Product Code: JWH
• UDI-Device Identifier: 00885556422793
• UDI-Public: 00885556422793
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74021164
• Device Catalogue Number: 74021164
• Device Lot Number: 20CM14943
• 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: 06/19/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 08/22/2023
• Date Device Manufactured: 03/18/2020
• 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: JRNY II CR ISRT XLPE LT SZ 1-2 10MM, LOT#:12JM1488.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown