Wagner SL Revision® 01.00109.809Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024278004), received between Jan 28, 2021 and Jun 19, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TRIAL OF A STEM, THE SET SCREW BROKE WHILE USING THE SLAPHAMMER. THE EXACT CAUSE OF THE BREAKAGE IS UNCERTAIN, BUT IT IS POSSIBLE THAT THE STEM WAS OVERSIZED OR NOT REAMED SUFFICIENTLY DISTALLY. AT THE TIME OF THE BREAK, THE DEVICE WAS LOCATED INSIDE THE FEMORAL CANAL. TO REMOVE THE DEVICE, AN OSTEOTOMY WAS REQUIRED. IT IS LIKELY THAT DEVIATING FROM THE RECOMMENDED TECHNIQUE, SPECIFICALLY OVER-REAMING OR INADEQUATE REAMING DISTALLY, CONTRIBUTED TO THIS INCIDENT. THE OVERALL DELAY CAUSED BY THIS EVENT WAS APPROXIMATELY ONE HOUR. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17152026 ↗
• InjuryFeb 25, 2022Break; Fracture; Fracture

  IT WAS REPORTED THAT WHILE SURGEON WAS REMOVING WAGNER SL TRIAL STEM 16X190MM, THE SCREW BROKE, LEAVING IN THE FEMORAL CANAL THE DISTAL 16MM TRIAL. AFTER ADEPTS AT EXTRACTING DISTAL TRIAL STEM, SURGEON PERFORMED OSTEOTOMY TO RETRIEVE DISTAL TRIAL STEM. PATIENT INVOLVEMENT - PROLONGED SURGERY 60 MINUTE DELAY.

  Patient problems: Insufficient Information

  MAUDE report 13599223 ↗
• MalfunctionDec 2, 2021Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  IT WAS REPORTED THAT WHEN TAKING STEM OFF OF THE NECK, THE TRIAL SCREW BECAME STUCK IN THE NECK. WHILE TRYING TO GET THE SCREW OUT, IT BECAME STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12916640 ↗
• MalfunctionDec 2, 2021Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT A SCREW HEAD STRIPPED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12915043 ↗
• InjuryJan 28, 2021Fracture; Fracture

  NO CHANGE TO PREVIOUSLY REPORTED EVENT.

  Patient problems: Foreign Body In Patient; Limb Fracture

  MAUDE report 11242714 ↗