MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 7-8 RT 9; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74023271
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after tka surgery had been performed on an unknown date, the patient experienced completely break post from the poly.This adverse event was addressed by revision surgery on (b)(6) 2022 to explant the journ art ins bcs std 7-8 rt 9.The surgeon was able to recovered two main pieces and some small fragments from the broken post.Current health status of patient is unknown.
Additional Manufacturer Narrative
H6: health effect- impact code.Section h3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that responses to the clinical requests have not been provided as of the date of this medical investigation.The root cause of the reported breakage cannot be definitively concluded.The patient impact beyond the reported breakage, retrieval of pieces and revision could not be determined.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 instructions for use documents for knee systems revealed that fracture of the implant has been identified in possible adverse effects as result of trauma, strenuous activity, improper alignment, or duration of service.The patient should be warned that the device does not replace normal healthy bone, and 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 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.

• Brand Name: JOURN ART INS BCS STD 7-8 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: 13876895
• Report Number: 1020279-2022-01324
• Device Sequence Number: 4692255
• Product Code: JWH
• UDI-Device Identifier: 03596010555274
• UDI-Public: 03596010555274
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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: 74023271
• Device Catalogue Number: 74023271
• 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: 03/02/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 04/21/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown