MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II C/R FEM SIZE 5 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Damage to Ligament(s) (1952); Deformity/ Disfigurement (2360); Joint Dislocation (2374); Inadequate Osseointegration (2646)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a left tkr surgery performed approximately 2 years ago, the patient experienced a catastrophic failure of the medial collateral ligament.This adverse event was treated by revision surgery on (b)(6) 2026, during which a hinged prosthesis was required.As a result, the gns ii c/r fem size 5 left and gns ii cmt tib size 4 left were removed.Current health status of patient is unknown.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).Additional information on: corrected data on: h6 (clinical code).
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the electronic left lateral x-ray appears to show an accentuated valgus-aligned left knee with widening of the medial joint compartment, radiolucency between the left tibial component cement mantle/bone interface and radiolucency underneath the femoral component and around the stem.Additionally, the anterior/posterior image appears to show tibial baseplate overhang, medially.Dated, interval and/or comparison imaging was not provided.Of note, the articulating insert appears to be on the thicker side with incongruent polyethylene articulating space on anterior/posterior image.Micro/macro-motion of components would contribute to joint instability and place excessive stress on the medial collateral ligament (mcl).The date of onset of any signs/symptoms, patient comorbidities, or potential trauma was not provided, and the current patient health status is unknown.Based on the radiolucencies noted in the provided imaging, component loosening could have led to micro and macro-motion of the left knee joint implants which would place increased stress on the mcl.Alternatively, intraoperative preservation or post-operative ligament trauma cannot be ruled out as a precipitating event.Although component positioning/valgus presentation (malalignment) are suspect; the definitive clinical root cause of reported ¿catastrophic failure of the mcl¿ cannot be confirmed based on the imaging alone.The patient impact includes the valgus left total knee arthroplasty/malalignment with widening of the medial joint compartment, radiolucencies, suspected micro/macro-motion, reported ¿catastrophic failure of the mcl¿ and revision/conversion to a hinged knee prosthesis.Device batch numbers were not provided; thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed devices.A review of the instructions for use documents for knee systems revealed that warnings and precautions states that the patient should be warned of surgical risks and made aware of possible adverse effects.The patient should be warned that the implant can become damaged as a result of strenuous activity or trauma.Besides, possible adverse effects section states that temporary or permanent nerve damage can result in pain or numbness of the affected limb.Periodic, long-term follow-up is recommended to monitor the position and state of the prosthetic components, as well as the condition of the adjoining bone.A review of the risk management files 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 these products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should the devices 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.Corrected data: b5, h6 (health effect - clinical code).
Event or Problem Description
It was reported that, approximately 2 years after left tkr surgery was performed, the patient experienced a catastrophic failure of the medial collateral ligament.This adverse event was treated by revision surgery on (b)(6) 2026, during which a hinged prosthesis was required.As a result, the gns ii c/r fem size 5 left, gns ii cmt tib size 4 left and the insert were removed.Current health status of patient is unknown.

• Brand Name: GNS II C/R FEM 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 24199287
• Report Number: 1020279-2026-00119
• Device Sequence Number: 9624761
• Product Code: JWH
• UDI-Device Identifier: 03596010205452
• UDI-Public: 3596010205452
• 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: 2026
• 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,Followup
• Report Date (Section B): 02/20/2026

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 Catalogue Number: 71420008
• Device Lot Number: UNKNOWN
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 01/28/2026; 02/20/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 01/28/2026; 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 71420166
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female