MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 3-4 11; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71421509
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that, after tka surgery had been performed on (b)(6) 2006, the patient experienced discomfort in the left knee.This adverse event was treated by revision surgery on (b)(6) 2025 revealing that the post part of the insert had fractured, in which only the gii ps hi flex isrt sz 3-4 11 was exchanged.Current health status of patient is unknown.
Additional Manufacturer Narrative
Corrected data: b5, h6 (medical device problem code).
Event or Problem Description
It was reported that, after tka surgery had been performed on (b)(6) 2006, the patient experienced discomfort in the left knee.This adverse event was treated by revision surgery on (b)(6) 2025 revealing that the post part of the gii ps hi flex isrt sz 3-4 11 had fractured, so the gii ps hi flex isrt sz 3-4 11 was exchanged.Current health status of patient is unknown.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection revealed that the device returned significantly worn and discolored.One area of the posterior edge of the superior surface is deformed with significant material loss and the post is fractured off and returned with the device.The insertion/extraction slot on the inferior surface is fractured and the lock detail is slightly deformed in several areas.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 for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed in warnings and precautions that the implant can break or become damaged as a result of strenuous activity or trauma.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 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.According to the material specifications, the quality and manufacture of polyethylene shall be controlled.This material is used in the manufacture of surgical implants and instruments and can be considered a surgical grade of polyethylene.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.The observed deformation and/or fracture of the implant may be attributed to abnormal loading conditions, excessive mechanical forces, anatomical variations and/or patient anatomy, and/or injury.Additionally, based on the conclusions of the product history review and the device evaluation, further product evaluation is not required because there is no evidence that a manufacturing deficiency occurred.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.Additional information: d9.

• Brand Name: GII PS HI FLEX ISRT SZ 3-4 11
• 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: 23460409
• Report Number: 1020279-2025-01832
• Device Sequence Number: 10431945
• Product Code: JWH
• UDI-Device Identifier: 03596010492364
• UDI-Public: 3596010492364
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2025
• 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): 03/26/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/04/2016
• Device Catalogue Number: 71421509
• Device Lot Number: 06FT98837
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 12/05/2025; 03/25/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/09/2025; 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2006
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female