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

Catalog Number	71420190
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery had been performed 9 years ago, the patient experienced anterior tibial pain in the last 4 month.A bone scan indicated gns ii non-por tib sz 7 right loosening.This adverse event was solved by revision surgery on (b)(6) 2023 where the tibial baseplate was exchanged.The current health status of patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The photographs were reviewed, and did not reveal any defects that would prevent the device from working/functioning as intended.The clinical/medical investigation concluded that, the provided image shows an explanted insert with the tibial component which appears to support the complaint, as no visible cement appears to be adhered to the tibial stem.Based on the limited documentation provided, the reported lack of bone cement/bonding to the tibial baseplate led to the reported tibial component loosening and anterior tibial pain.The patient impact included the symptomatic tibial baseplate loosening and subsequent revision which would include a transient post-operative restorative phase 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 similar events 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 has been identified as a 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 evidence to conclude that the product failed to meet any specifications at the time of manufacture.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.Additional information: d4 (expiration date), h4 corrected data: d4 (lot number).

• 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
• 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: 18454989
• Report Number: 1020279-2024-00024
• Device Sequence Number: 3100355
• 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: 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): 02/12/2024

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: 11/19/2023
• Device Catalogue Number: 71420190
• Device Lot Number: 13LT36891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2013
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71453231/13LT36891/LGN PS HIGH FLEX XLPE SZ 7-8 9M
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown