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	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after tka, a revision surgery was performed due to a genesis ii non-porous tibial baseplate size 5 right loosening.The outcome of the patient is unknown.
Additional Manufacturer Narrative
It was reported that after tka, a revision surgery was performed approximately 28 months post implantation due to a genesis ii non-porous tibial baseplate size 5 right loosening.The outcome of the patient is unknown.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes that could have caused or contributed to the reported incident.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 batch with the same failure mode.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.A medical analysis noted that the provided undated/unidentified images appear to show radiolucency of the tibial stem, appearing greater in the posteromedial area consistent with the reported complaint.No further clinically relevant documentation or event details were provided for inclusion in the medical investigation.Some potential causes could include but are not limited to fit/sizing, traumatic injury, abnormal motion over time, poor bone quality or patient medical history.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.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: 11086753
• Report Number: 1020279-2020-07859
• Device Sequence Number: 3310989
• Product Code: JWH
• UDI-Device Identifier: 03596010206350
• UDI-Public: 03596010206350
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

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 Model Number: 71420186
• Device Catalogue Number: 71420186
• Device Lot Number: H1801453
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CN: 71453223, LN: 18AT97585; CN: 71453223, LN: 18AT97585
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention