MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 5 RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420186
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tkjr surgery had been performed on (b)(6) 2012, the patient x-ray showed that the gns ii cmt tib size 5 right is worn.When the gns ii cmt tib size 5 right was removed, there was no cement on the back of the implant, indicating that the product failed and had the cement/implant interface.The adverse event was addressed with a revision surgery on (b)(6) 2021.The condition of the patient is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the failure of the cement/implant interface was confirmed.The clinical/medical investigation concluded that, the surgical technique advises to ¿apply cement on the proximal tibia and/or the implant and seat the tibial implant with the tibial impactor.¿ the information and imaging provided appear to support the failure of the cement/implant interface; however, the root cause of the reported event could not be fully assessed without the operative reports and return of the explanted components.It is unknown if the type of bone cement applied could have contributed to the reported event, but the failure is more than likely related to the cement and not to the device itself.The assessed patient impact was the reported failure at the cement/implant interface and subsequent revision tka.Further patient impact could not be assessed based on the information provided.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 did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Potential causes could include but are not limited to patient condition, lifetime of device, surgical technique used or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.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: GNS II CMT TIB SIZE 5 RIGHT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12386522
• Report Number: 1020279-2021-06589
• Device Sequence Number: 14354942
• Product Code: JWH
• UDI-Device Identifier: 03596010206350
• UDI-Public: 03596010206350
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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: 05/08/2022
• Device Model Number: 71420186
• Device Catalogue Number: 71420186
• Device Lot Number: 12ET18476
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 10/01/2021
• 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