MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 3-4 LT10; PRTHSIS,KNEE,PATLLOFMORTIBL,SMI-CNSTRND,CMNTD,PLYMR/MTAL/PLYMR

Model Number	74023242
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed in (b)(6) 2020 due to implant failure.Insert was originally implanted in a female patient in 2008.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.The returned device was examined visually.On the returned component damage / deformation was observed on the articular surface of the insert; these features have been reported as being created by third-body particulate (bone cement, bone, etc.) in the joint space.Cement and bone particulate are known to be produced during a total knee arthroplasty, even under carefully controlled conditions.The insert post is also damaged and fractured from the body of the insert.Scratches and deformation were observed on the inferior surface of the insert.The discoloration was present on the superior and inferior surfaces of the insert.No material or manufacturing deviations were observed.The device was manufactured in 2007.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Our clinical / medical team noted: no clinical / medical documentation was submitted for this investigation.Without supporting clinical / medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.The root cause of the break cannot be definitively concluded however, it may have been wear on the articular surface created by third-body particulate as noted in the product evaluation.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: JOURN ART INS BCS STD 3-4 LT10
• Common Device Name: PRTHSIS,KNEE,PATLLOFMORTIBL,SMI-CNSTRND,CMNTD,PLYMR/MTAL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9774028
• Report Number: 1020279-2020-00746
• Device Sequence Number: 1568110
• Product Code: JWH
• UDI-Device Identifier: 03596010555076
• UDI-Public: 03596010555076
• Combination Product (Y/N): N
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2017
• Device Model Number: 74023242
• Device Catalogue Number: 74023242
• Device Lot Number: 07DM10038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 11/05/2020
• 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