MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II NON-POR TIB SZ 7 RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420190
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka, a revision surgery of a genesis ii tkr was performed on (b)(6) 2021 due to aseptic loosening.Both tibial and patella components were loose.Both implants had failed at the cement/implant interface.There was no cement at all still attached to the tibial component.There were no obvious signs of abnormal wear patterns and the knee looked well aligned in imaging post primary tkr.The lgn ps high flex xlpe sz 7-8 9mm ((b)(4)), gns ii resurf pat 32mm ((b)(4)) and gns ii non-por tib sz 7 right ((b)(4)) were explanted.The current health status of patient and the initial surgery date is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation but the images provided were reviewed, and the loosening was confirmed.The clinical/medical investigation concluded that, 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 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 aseptic loosening/ failure at the cement/implant interface and subsequent revision tka.Further patient impact could not be assessed based on the information provided.No further medical assessment could be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.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.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.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing, lack of ingrowth and/or traumatic injury.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.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation but the images provided were reviewed, and the loosening was confirmed.The clinical/medical investigation concluded that, 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 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 aseptic loosening/ failure at the cement/implant interface and subsequent revision tka.Further patient impact could not be assessed based on the information provided.No further medical assessment could be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.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.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.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing, lack of ingrowth and/or traumatic injury.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: GNS II NON-POR TIB SZ 7 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: 12119180
• Report Number: 1020279-2021-05716
• Device Sequence Number: 4429232
• Product Code: JWH
• UDI-Device Identifier: 03596010206374
• UDI-Public: 03596010206374
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2021

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: 10/03/2025
• Device Model Number: 71420190
• Device Catalogue Number: 71420190
• Device Lot Number: 15KM03790
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 09/08/2021; 09/22/2021
• Initial Report FDA Received Date: 07/05/2021
• Supplement Report FDA Received Date: 09/09/2021; 09/23/2021
• 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