MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 7-8 LT15; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74023285
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a tka surgery (date of original implantation unknown), a journey 1 7-8 15mm insert broke inside the patient and there was a revision surgery to explant on (b)(6) 2021.Implant was replaced with a journey 1 rev insert and new journey 35mm patella.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the broken device was confirmed.The clinical/medical investigation concluded that, no relevant clinical information, implantation/revision report or radiographs have been provided.Therefore, a thorough medical investigation cannot be rendered nor could a root cause be determined.Per the complaint details, the journey 1 7-8 15mm insert broke inside the patient and a revision was performed to explant the broken insert and replaced it with a journey 1 rev insert and new journey 35mm patella.Therefore, the impact to the patient beyond that which has already been reported cannot be determined.Should any additional medical information be provided, this complaint would be re-assessed.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.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.
Event or Problem Description
It was reported that after a tka surgery (date of original implantation unknown), a journ art ins bcs std 7-8 lt15 broke inside the patient and there was a revision surgery to explant on (b)(6) 2021.Implant was replaced with a journey 1 rev insert and new journey 35mm patella.
Additional Manufacturer Narrative
The device was not returned for evaluation.However, the photographs were reviewed, and revealed that the post of the insert broke.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months 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 has been identified as a 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 review of the risk management file revealed this failure mode was previously identified.A review of previous actions concluded that there is a higher than expected risk of revision surgery for the first generation of journey bcs systems.It was recommended to undertake a field safety corrective action to inform surgeons of the higher expected risk of revision, and ensure clear communication that the device should only be used for polyethylene exchange revision of journey bcs total knee constructs where the femoral component and tibial baseplate are well fixed.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected, surgical technique, postoperative care, patient anatomy, abnormal loading of limb, excessive forces and/or injury.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.

• Brand Name: JOURN ART INS BCS STD 7-8 LT15
• 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: 11943745
• Report Number: 1020279-2021-05027
• Device Sequence Number: 4318566
• Product Code: JWH
• UDI-Device Identifier: 03596010555380
• UDI-Public: 3596010555380
• 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 Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/23/2025

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 Catalogue Number: 74023285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 08/12/2021; Not provided; 02/20/2025
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 08/13/2021; 01/07/2025; 02/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown