MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 RT 9; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74023251
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient complained of instability on the right knee after primary tkr was performed.No falls were reported prior to the event.The patient underwent revision surgery to change the articular insert from 9 mm to 15 mm.The insert was found to have its base separated from the implant.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The tip of the post on the device fractured off and was returned.The device was manufactured in 2007 and shows signs of extensive wear.The medical investigation concluded that, without information regarding the patient¿s medical history, bone quality, radiographic images or operative reports, the root cause of the instability could not be concluded.The surgeon¿s intraoperative findings of the articulating insert separation from the base cannot be ruled out as a contributing factor.This event occurred 12 years post implant and the replacement insert was 6mm thicker indicating increasing joint laxity.It is unknown if this also played a role in the disassociation and/or breakage of the insert.The impact to the patient beyond the revision cannot be determined.Should any additional medical information be provided this complaint would be re-assessed.The knee insert post deformation and/or fracture may have been due to repeated posterior contact of the femoral cam on the post combined with excessive posterior to anterior shear force during activity.However, this could not be isolated as the root cause for this particular failure mode.A review of complaint history did not reveal additional complaints for the listed batch.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 documents revealed this failure mode was previously identified.Some potential probable causes for this event could include a sizing issue, overuse or a traumatic injury.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: JOURN ART INS BCS STD 5-6 RT 9
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9776434
• Report Number: 1020279-2020-00755
• Device Sequence Number: 11155034
• 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 Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2020

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: 07/15/2017
• Device Model Number: 74023251
• Device Catalogue Number: 74023251
• Device Lot Number: 07GM12429
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 06/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention