MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 5-6 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71421515
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka had been performed on (b)(6) 2025, the gii ps hi flex isrt sz 5-6 9mm dislocated.This adverse event was addressed by performing a revision surgery on (b)(6) 2026, during which, the gii ps hi flex isrt sz 5-6 9mm was exchanged to an equivalent insert.Patient's current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).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.H11: e1 (phone number) (b)(6).
Event or Problem Description
It was reported that, after a tka had been performed on (b)(6)2025, the gii ps hi flex isrt sz 5-6 9mm dislocated.This adverse event was addressed by performing a revision surgery on (b)(6)2026, during which, the gii ps hi flex isrt sz 5-6 9mm was exchanged to an equivalent insert.Patient is currently doing well.
Additional Manufacturer Narrative
Internal complaint reference:(b) (4) additional information: b5: describe event or problem, h6: type of investigation and investigation findings h11: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that.¿ the provided photocopied x-rays (b)(6)2025 show a shadow protruding anteriorly in the articulating joint space consistent with an anteriorly displaced insert which supports the complaint.Post-revision images (b)(6)2025 do not provide insight into the root cause of the event and immediate post-implantation images were not provided.Successful locking of the primary articulating insert cannot be confirmed in the imaging.The instructions for use for knee systems revelaed that possible adverse effects includes dislocation which can result from trauma, improper implant selection, improper implant positioning, improper fixation, migration and/or muscle and fibrous tissue laxity.It is unknown if the patient experienced any precipitating trauma.Correspondence stated, ¿a few months postoperatively, the inlay dislocated¿ and ¿problem detected clinically + radiologically ¿and was resolved with an equivalent insert exchange.It was reported that the patient is doing well at the moment and the postoperative course has been unremarkable so far.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 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.Factors that could contribute to the reported event include injury, patient condition, postoperative care, size selected or abnormal loading of limb.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.

• Brand Name: GII PS HI FLEX ISRT SZ 5-6 9MM
• 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: 24506030
• Report Number: 1020279-2026-00294
• Device Sequence Number: 9943052
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 05/21/2026

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: 71421515
• Device Lot Number: 24KM03013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Female