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Wagner SL Revision® 01.00109.805Recalls & reported problems

Zimmer GmbH · Class 2

All models of Wagner SL Revision (33)

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

Adverse event reports
7
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024277960), received between Dec 4, 2018 and Oct 28, 2021 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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

Device problems

  • Fracture6
  • Mechanical Jam1
  • Mechanical Problem1
  • Physical Resistance/Sticking1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • Insufficient Information2
  • Tissue Damage2
  • Failure of Implant1
  • No Information1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 28, 2021Fracture; Fracture

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

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

    MAUDE report 12712250 ↗
  • MalfunctionJul 30, 2021Fracture; Mechanical Problem; Mechanical Jam; Fracture; Mechanical Problem; Mechanical Jam

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

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

    MAUDE report 12251492 ↗
  • InjuryMay 19, 2021Fracture; Fracture

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

    MAUDE report 11848769 ↗
  • InjuryNov 28, 2019Fracture; Fracture

    EVENT HAPPENED DURING THE SURGERY WHEN THE PROXIMAL BODY TRIAL FRACTURED FROM THE DISTAL BODY TRIAL. LOCKING SCREW WAS ALSO FRACTURED DURING THE SAME EVENT. IT IS UNKNOWN WHETHER ALL THE BROKEN PIECES WERE REMOVED FROM PATIENT.

    Patient problems: No Information

    MAUDE report 9390045 ↗
  • InjuryApr 25, 2019Fracture; Fracture

    IT WAS REPORTED THAT WHEN SURGEON TRIED TO REMOVE THE STEM TRIAL AFTER FINISHING TRIAL-REDUCTION, THE SCREW BROKE INSIDE THE DISTAL TRIAL, AND MADE IT IMPOSSIBLE TO RETRIEVE THE DISTAL TRIAL FROM THE CANAL. AN OSTEOTOMY HAD TO BE PERFORMED TO TAKE OUT THE INSTRUMENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Patient problems: Tissue Damage

    MAUDE report 8548700 ↗
  • InjuryApr 25, 2019Fracture; Fracture

    IT WAS REPORTED THAT WHEN SURGEON TRIED TO REMOVE THE STEM TRIAL AFTER FINISHING TRIAL-REDUCTION, THE SCREW BROKE INSIDE THE DISTAL TRIAL, AND MADE IT IMPOSSIBLE TO RETRIEVE THE DISTAL TRIAL FROM THE CANAL. AN OSTEOTOMY HAD TO BE PERFORMED TO TAKE OUT THE INSTRUMENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE

    Patient problems: Tissue Damage

    MAUDE report 8548248 ↗
  • MalfunctionDec 4, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

    PLEASE REFER TO REPORT 0009613350-2018-01183.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8127968 ↗

Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices

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Sources and updates

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