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TRIGEN 71931663Recalls & reported problems

Smith & Nephew, Inc. · KNEE FUSION FEM ANTEGRADE NAIL LEFT 13MM X 75CM · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010609588), received between Dec 18, 2020 and Dec 18, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K050938, K210980); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Delivered as Unsterile Product1
  • Packaging Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 18, 2020Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

    IT WAS REPORTED THAT, WHEN THE KNEE FUSION IMPLANT WAS OPENED FOR USE IN SURGERY, THE INTERNAL PLASTIC PACKAGING WAS NOTICED DAMAGED. IT WAS NOT USED SINCE STERILITY COULD NOT BE CONFIRMED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11037917 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050938, K210980. One submission often covers many models, so check the product and lot details in each record.

  • Z-2456-2026 · Mar 16, 2026 · Open, Classified
    TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
  • Z-1806-2025 · Mar 18, 2025 · Open, Classified
    META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
  • Z-2443-2023 · Jul 24, 2023 · Open, Classified
    TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
  • Z-2444-2023 · Jul 24, 2023 · Open, Classified
    TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail

Other NAIL, FIXATION, BONE devices

All NAIL, FIXATION, BONE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.