MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 RT 9; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74023251
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, after total knee arthroplasty was performed on an unknown date, the patient experienced instability and felt that something was floating in their knee.A computed tomography showed a possible piece in the knee joint.This adverse event was treated with revision surgery on (b)(6) 2022, in which the poly was explanted and replaced with a journey i revision poly; in addition, the broken piece was retrieved.Patient's current health status is unknown.
Event or Problem Description
It was reported that, after total knee arthroplasty was performed on (b)(6) 2009, the patient experienced instability and felt that something was floating in their knee.A computed tomography showed a possible piece in the knee joint.This adverse event was treated with revision surgery on (b)(6) 2022, in which the poly was explanted and replaced with a journey i revision poly; in addition, the broken piece was retrieved.Patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation but the pictures were reviewed, and revealed that the insert is broken.The clinical/medical investigation concluded that the provided primary implant record and photos of the explanted insert were assessed; however, no clinical factors were noted which would have contributed to the event.The patient's current health status, medical history and comorbidities are unknown.The patient impact beyond that which was reported could not be determined.No further medical assessment is warranted at this time.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 revealed similar events for the listed device 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.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.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 be corroborated as the device was damaged and it was required a revision surgery to treat this event.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 5-6 RT 9
• 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: 15108276
• Report Number: 1020279-2022-03479
• Device Sequence Number: 12119570
• Product Code: JWH
• UDI-Device Identifier: 03596010555137
• UDI-Public: 03596010555137
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2022

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: 05/29/2018
• Device Model Number: 74023251
• Device Catalogue Number: 74023251
• Device Lot Number: 08EM22082
• 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: 07/07/2022
• Supplement Date Received by Manufacturer: 07/25/2022; 08/23/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 07/27/2022; 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2008
• 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: 71932912/JRNY 7.5 RND RSRF PAT 32MM STD; 74021116/JOURNEY FEM OX NP BCS RT SZ 6; 74022215/JOURNEY TIBIA BASE NP RT SZ 5
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown