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T2 1825-1036SRecalls & reported problems

Stryker GmbH · Femoral Nail, A,R · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540199515), received between Nov 24, 2020 and Mar 12, 2025 — classified as 4 injuries.

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

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 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 2 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Biocompatibility1
  • Fracture1

Patient problems

  • Failure of Implant1
  • Impaired Healing1
  • Implant Pain1
  • Metal Related Pathology1
  • Nonunion/Delayed-union Bone Fracture1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 12, 2025Biocompatibility; Biocompatibility

    AS PER THE LEGAL DEPARTMENT'' BGHM (BERUFSGENOSSENSCHAFT HOLZ UND METALL) INSURANCE HAVE REPORTED THAT THERE IS AN INCREASE IN LEAD, CHROMIUM, COBALT, ZINC AND CADMIUM HAS BEEN DETECTED IN THEIR INSURED¿S BLOOD AND URINE. AN ALLEGATION HAS BEEN MADE BY THE INSURED PATIENT¿S TREATING PHYSICIAN THAT THIS COMPLAINT MAY BE DUE TO THE T2 FEMORAL NAIL IMPLANTED IN THE PATIENT IN 2007."

    Patient problems: Metal Related Pathology

    MAUDE report 21587628 ↗
  • InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, PERSISTENT PAIN WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

    Patient problems: Implant Pain

    MAUDE report 19938634 ↗
  • InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, DELAYED UNION WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

    Patient problems: Impaired Healing

    MAUDE report 19937998 ↗
  • InjuryNov 24, 2020Fracture; Fracture

    THE CUSTOMER REPORTED A BROKEN NAIL. PATIENT ARRIVES AT THE CLINIC WITH A BROKEN NAIL AND A BROKEN DISTAL SCREW. NO TRAUMA APPARENT, NO FURTHER HISTOLOGICAL FINDINGS, NON-UNION, NO CALCIFICATION VISIBLE IN THE FRACTURE GAP. REVISION SURGERY WITH THE "SLIDING NAIL" (COMPANY INTERCUS) SLIDE 12MM.

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

    MAUDE report 10891743 ↗

Other ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices

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Sources and updates

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