TRIGEN 71645047Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556215944), received between Nov 5, 2022 and Dec 20, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM A MILD LOOSENING OF A SCREW, WITH SIMILAR PROTRUSION BEYOND THE MEDIAL FEMORAL CORTEX, AFTER HAVING A FRACTURE FIXATION SURGERY OF A LEFT FEMUR FRACTURE USING THE TRIGEN TAN SYSTEM. THE PATIENT DID NOT UNDERGO ANY MEDICAL INTERVENTION TO ADDRESS THE ISSUE. IT IS UNKNOWN IF THE PATIENT ACHIEVED UNION. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN. 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: Failure of Implant; Inadequate Osseointegration

  MAUDE report 16016856 ↗
• InjuryNov 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION PROCEDURE HAD BEEN PERFORMED ON THE PATIENT'S LEFT FEMUR ON (B)(6) 2017 TO TREAT A TROCHANTERIC FRACTURE, THE PATIENT EXPERIENCED PAIN IN THE BACK, IN THE KNEE AND IN THE LATERAL HIP OVER THE GREATER TROCHANTER. ALONG WITH THIS SYMPTOM, THE PATIENT ALSO EXPERIENCED TROCHANTERIC BURSITIS OF THE LEFT HIP AND THE BREAKAGE OF ONE (1) DISTAL SCREW. THE PATIENT RECEIVED A STEROID INJECTION IN OR AROUND (B)(6) 2018, BUT THERE IS NO EVIDENCE OF HOW WAS THE SCREW FRACTURE ADDRESSED. ADDITIONAL DETAILS REGARDING THE CLINICAL COURSE OF THE PATIENT WERE NOT PROVIDED. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF)], ADDITIONAL INFORMATION IS NOT KNOWN, AND IT IS NOT POSSIBLE TO COLLECT IT, WE DO NOT HAVE THE OPPORTUNITY TO REVISIT NEGATIVE FEEDBACK TO RETRIEVE FURTHER INFORMATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Inflammation; Pain

  MAUDE report 15741045 ↗

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-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
• 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