MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 3-4 LT 9; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74023241
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	07/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tka was performed on (b)(6) 2008, patient presented with anterior/posterior instability.A revision surgery was performed on (b)(6) 2022 to replace the journ art ins bcs std 3-4 lt 9 with a j2 crdd of the same size.Upon revision, the post of the journ art ins bcs std 3-4 lt 9 was found to be fractured.The current health status of the patient is unknown.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was found to be fractured along the post of the device, rendering the device inoperative.The device shows signs of prolonged use.The fractured component was also returned.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.The clinical/medical evaluation concluded that per complaint details, a revision was performed approximately 14.5 years post implantation due to a/p instability with an intraoperative finding of a fractured post from the articulating insert.It was communicated that the surgeon has not responded in regard to the requested medical documentation and the patient current health status remains unknown.The knee system ifu/possible adverse effects addresses fracture of implant components may occur and warns components have a finite expected service life and may need to be replaced.Without the requested medical documentation, no definitive clinical factors could be concluded which would have contributed to the reported event; however, the length of time in-vivo could not be ruled out.Patient impact beyond the reported instability and revision with an anticipated recovery phase could not be further assessed.No further medical assessment can 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.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.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 3-4 LT 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: 15203305
• Report Number: 1020279-2022-03619
• Device Sequence Number: 6241790
• Product Code: JWH
• UDI-Device Identifier: 03596010555069
• UDI-Public: 03596010555069
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/14/2018
• Device Model Number: 74023241
• Device Catalogue Number: 74023241
• Device Lot Number: 08MM13506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2008
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown