TRIGEN 71645042Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556215845), received between Dec 15, 2021 and Dec 20, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K111025, K161264, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM A FALL AND BROKE THE DISTAL INTERLOCKING SCREW AFTER HAVING A FRACTURE FIXATION SURGERY OF THE RIGHT FEMUR USING THE TRIGEN TAN SYSTEM. OVERALL, THE ALIGNMENT REMAINED INTACT, AND THE SCREW HAD NO MIGRATION. THE PATIENT ACHIEVED UNION AT 8 WEEKS AFTER THE PRIMARY SURGERY. NO HARDWARE REVISION SURGERY WAS SCHEDULED, AND THE PATIENT WAS LOST TO FOLLOW UP. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN, AND IT IS NOT POSSIBLE TO COLLECT IT. WE DO NOT HAVE THE OPPORTUNITY TO IDENTIFY INDIVIDUAL HCPS AND REVISIT NEGATIVE FEEDBACK TO RETRIEVE FURTHER INFORMATION

  Patient problems: Arthralgia; Failure of Implant; Fall; Implant Pain

  MAUDE report 16013913 ↗
• InjuryDec 15, 2021Fracture; Fracture

  IT WAS REPORTED THAT, AFTER AN OPEN REDUCTION WITH OSTEOSYNTHESIS HAD BEEN PERFORMED ON (B)(6) 2018 TO TREAT AN INTERTROCHANTERIC FEMORAL NECK MULTIFRACTURE, THE PATIENT EXPERIENCED PSEUDOARTHROSIS WITH A NONUNION OF THE TREATED FEMORAL FRACTURE, A RIGHT LEG LENGTH DISCREPANCY, ANTEFLEXION DEFORMITY AND THE FRACTURE OF THE INTERTAN 11.5MM X 38CM 125D RT ALONG WITH THE BREAKAGE OF A TRIGEN LOW PROFILE SCREW 5.0MM X 42.5MM. A REVISION SURGERY WAS PERFORMED ON(B)(6) 2021 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE NAIL AND SCREWS WERE REMOVED, AND A HIP JOINT REPLACEMENT CONSTRUCT WAS IMPLANTED. THE PATIENT¿S OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture; Unequal Limb Length

  MAUDE report 13011240 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111025, K161264, 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-2444-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
• 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-1132-2013 · Mar 6, 2013 · Terminated
  TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery