MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 RT10; PROSTHESIS, KNEE, PATELLOFEMOR, SEMI-CONS, CEMENTED, POLYMER/METAL/POLYMER

Model Number	74023252
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a simultaneous bilateral tka had been performed on (b)(6)2010, the patient experienced a post fracture of the tibial insert in one of the knees.Due to this incident, an emergency revision surgery was performed on an unspecified date.The identity of the explanted devices and of the devices implanted in exchange during this procedure are unknown at this time.The patient wants a revision of the other knee tibial insert, although no apparent adverse event/malfunction has been reported with this prosthesis.The patient's current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H6, removed code 4648 - insufficient information.
Event or Problem Description
It was reported that, after a simultaneous bilateral tka had been performed on (b)(6) 2010, the patient experienced a right knee - post fracture of the tibial insert, allowing subluxation of the knee with activity.Due to this incident, an emergency revision surgery was performed on (b)(6) 2021.During this procedure, all the devices from the construct were explanted and replaced with an unspecified system.The patient wants a revision of the other knee tibial insert, although no apparent adverse event/malfunction has been reported with this prosthesis.The patient's current health status is unknown.
Additional Manufacturer Narrative
The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, smith and nephew has not received the device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history 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 for the listed device.A review of the instructions for use documents for knee systems revealed 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 has been identified in the warnings and precautions.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.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.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 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.

• Brand Name: JOURN ART INS BCS STD 5-6 RT10
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOR, SEMI-CONS, CEMENTED, POLYMER/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: 14548491
• Report Number: 1020279-2022-02685
• Device Sequence Number: 5172567
• Product Code: JWH
• UDI-Device Identifier: 03596010555144
• UDI-Public: 03596010555144
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2022

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 Expiration Date: 04/28/2018
• Device Model Number: 74023252
• Device Catalogue Number: 74023252
• Device Lot Number: 08DM01864
• 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: 05/11/2022
• Supplement Date Received by Manufacturer: 06/13/2022; 07/12/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 06/21/2022; 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2008
• 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: 74021115/09LM05961 - JOURNEY FEM OX NP BCS RT SZ 5.; 74022215/08KM04695 -JOURNEY TIBIA BASE NP RT SZ 5.; 74024829/09GM15620 -JRNY BCS PAT RESRF RD 29 MM ST.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male