MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 7-8 RT10; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74023272
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a surgery had been performed on an unknown date, the patient experienced knee dislocation, further investigation revealed the patient had a broken poly component.This adverse event was solved by revision surgery on (b)(6) 2022.The current health status of patient is unknown.
Additional Manufacturer Narrative
H10: h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a revision was performed after patient presented to the er complaining of a knee dislocation and per further investigation, a broken poly.It was communicated that the requested clinical documentation was not available.Without the requested clinical documentation, the root cause of the reported event could not be further assessed.The patient impact beyond the reported knee dislocation and broken poly insert with subsequent revision could not be determined.The current patient 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.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 fracture of the implant components has been identified as a possible adverse effect that may occur as a result of trauma, strenuous activity, improper alignment, or duration of service.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 RT10
• 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: 14952078
• Report Number: 1020279-2022-03264
• Device Sequence Number: 20569077
• Product Code: JWH
• UDI-Device Identifier: 03596010555281
• UDI-Public: 03596010555281
• 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 Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2022

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 Expiration Date: 04/23/2018
• Device Model Number: 74023272
• Device Catalogue Number: 74023272
• Device Lot Number: 08DM21967
• 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: 06/16/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 08/06/2022
• Date Device Manufactured: 04/25/2008
• 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