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

Model Number	71420168
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery done on (b)(6) where a gns ii cmt tib size 5 left was implanted, a revision surgery was executed on (b)(6) 2023 due to the loosening of the tibial component.The surgeon has suggested that the loosening occurred at the cement-implant interface, and not the cement-bone interface.The patient's current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Additional information: d10 (concomitant product added), h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the associated device was returned and evaluated.A visual inspection of the returned devices did not reveal the stated failure mode.The devices shows signs of wear.The clinical/medical investigation concluded that, per complaint details, a total knee arthroplasty revision surgery was performed dues to loosening of the tibial component at the cement-implant interface per the surgeon.Implantation date is unknown.As of the date of this medical investigation, patient-specific supporting clinical documentation has not been provided.Therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported events cannot be determined with the limited information provided.No further clinical assessment can be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed a similar event for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed that looseness of components has been identified in possible adverse effects section as a result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, size selected, cement integrity, inadequate integration between the cement and bone/implant and/or traumatic injury.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 is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Corrected data: d9 and h3 (device was returned for evaluation).

• Brand Name: GNS II CMT TIB SIZE 5 {} LEFT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16570473
• Report Number: 1020279-2023-00588
• Device Sequence Number: 17317057
• Product Code: JWH
• UDI-Device Identifier: 03596010206275
• UDI-Public: 03596010206275
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

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: 11/23/2025
• Device Model Number: 71420168
• Device Catalogue Number: 71420168
• Device Lot Number: E1515604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 03/19/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71420830 / LOT: H1600765
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown