MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 7-8 LT10; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER

Model Number	74023282
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that on (b)(6) 2021, after a total knee arthroplasty was performed on (b)(6) 2010, the implanted journey articular insert bcs standard 7-8 left 10mm broke.This adverse event was solved with a revision surgery conducted on (b)(6) 2021.Patient¿s current health status is unknown.
Additional Manufacturer Narrative
Results of investigation: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was severely worn and damaged.The post was also fractured from the device.The fractured component was returned with the device.The device was also discolored along the surface likely from extended exposure to bodily fluids.A review of complaint history revealed similar events for the listed device, but no similar events for the batch, this failure mode will be monitored for future complaints for any necessary corrective actions.The clinical/medical evaluation concluded that this case reports the breakage of an insert and revision approximately 11 years after a tka.Per case details, the patient experienced luxation and breakage of the device.Two photocopies of the returned device were provided.The patient¿s current health status is unknown.No additional requested information was provided.Without the requested clinically relevant information for evaluation, the root cause of the reported insert breakage and luxation cannot be definitively concluded.Further patient impact beyond the reported luxation, insert breakage and revision could not be determined and the patient¿s current health status remains unknown.No further medical assessment could be rendered 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.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 file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.The manufacturing process of the device did not contribute to the reported event.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.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: JOURN ART INS BCS STD 7-8 LT10
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
• 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: 12911351
• Report Number: 1020279-2021-08462
• Device Sequence Number: 12002631
• Product Code: JWH
• UDI-Device Identifier: 03596010555359
• UDI-Public: 03596010555359
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2022

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: 04/30/2018
• Device Model Number: 74023282
• Device Catalogue Number: 74023282
• Device Lot Number: 08EM02058
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2008
• 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: A
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 135 KG