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	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a tka performed on (b)(6) 2008, the journ art ins bcs std 5-6 rt 9 broke.This adverse event was addressed via revision surgery on (b)(6) 2022.The patient is fit and healthy.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, a revision was performed in a ¿fit and healthy¿ patient approximately 13.5 years post implantation due to a broken insert-post.It was communicated that the requested documentation was not available.Without the requested documentation/the root cause of the reported broken insert-post cannot be definitively concluded.Although the patient was reportedly ¿fit and healthy¿, the patient impact beyond the reported revision could not be further assessed.No further medical assessment can be rendered at this time.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.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 instructions for use for this device revealed that cracking or fracture of implant components has been identified in possible adverse effect.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.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The post of the device is broken off, rendering the device inoperative.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.The clinical/medical evaluation concluded that per complaint details, a revision was performed in a ¿fit and healthy¿ patient approximately 13.5 years post implantation due to a broken insert-post.It was communicated that the requested documentation was not available.Without the requested documentation/the root cause of the reported broken insert-post cannot be definitively concluded.Although the patient was reportedly ¿fit and healthy¿, the patient impact beyond the reported revision could not be further assessed.No further medical assessment can be rendered at this time.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 revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of ifu for knee systems revealed that cracking or fracture of implant components has been identified in possible adverse effect as a result of trauma, strenuous activity, improper alignment, or duration of service.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique, or implant failure.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.As the device broke and it cannot longer fit its purpose, the contribution of the device to the reported event could be corroborated.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 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: 13542207
• Report Number: 1020279-2022-00733
• Device Sequence Number: 19947656
• Product Code: JWH
• UDI-Device Identifier: 03596010555137
• UDI-Public: 03596010555137
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2022

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 Model Number: 74023251
• Device Catalogue Number: 74023251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 03/17/2022; 06/01/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 03/20/2022; 06/06/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown