Tornier Perform MWM052Recalls & reported problems
Tornier, Inc. · Humeral Impactor Tip · Class 1
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00846832082803), received between Nov 28, 2022 and Jul 15, 2026 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Fracture” (15 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture15
- Break10
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 15, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25829368 ↗MalfunctionMar 17, 2026Fracture
IT WAS REPORTED THAT, THE STEM IMPACTOR TIP COMPONENT BROKE DURING IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24616806 ↗MalfunctionDec 17, 2025Fracture; Fracture
IT WAS REPORTED THAT THE SURGEON BROKE PLASTIC 3-4 TORNIER IMPACTOR TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827026 ↗MalfunctionNov 17, 2025Fracture; Fracture
BROKEN IMPACTOR TIP DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23576699 ↗MalfunctionNov 12, 2025Fracture; Fracture
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE WHILE BEING UNSCREWED FROM THE HANDLE FOLLOWING COMPLETION OF THE SURGICAL PROCEDURE. ADDITIONALLY, DURING POST-OPERATIVE DECONTAMINATION, IT WAS OBSERVED THAT THE GLENOSPHERE TRIAL HAD PLASTIC MATERIAL BROKEN OUT FROM THE BACK AROUND THE SCREW AREA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23538656 ↗MalfunctionSep 24, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE HANDLE MWM038 WAS ATTACHED TO THE AFFLICTED INSTRUMENT MWM052 AND IMPLANTING DWX3PS INTO THE PATIENT. THE IMPACTOR TIP MWM052 BROKE INTO TWO PIECES, ONE REMAINING ON THE HANDLE AND THE OTHER IN THE COLLAR OF THE STEM. THE PROSTHESIS WAS REMOVED FROM THE PATIENT, AND THE BROKEN IMPACTOR WAS TAKEN OUT OF THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23133120 ↗MalfunctionAug 29, 2025Crack; Crack
IT WAS REPORTED THAT THE TIP CRACKED DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22922237 ↗MalfunctionAug 12, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE 3/4 STEM IMPACTOR BROKE DURING THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22787249 ↗MalfunctionJun 10, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THERE IS A BROKEN MWM052 (PERFORM HUMERAL IMPACTOR TIP). THE AFFLICTED INSTRUMENT MWM052 WAS ATTACHED TO MWM038 WHILE IMPACTING MWX4SS INTO THE PATIENT. MWM052 BROKE INTO TWO PIECES WHICH WERE REMOVED, A BACKUP TRAY WAS OPENED, AND THE SURGERY WAS CONTINUED NORMALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22175695 ↗MalfunctionJun 3, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE IMPACTOR TIP WAS FOUND BROKEN IN TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22134859 ↗MalfunctionApr 22, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE IMPACTOR TIPS BROKE UPON IMPACTION WHILE TRAILING THE STEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21883859 ↗MalfunctionJun 17, 2024Break; Fracture; Break; Fracture
THIS EVENT IS REPORTABLE TO NOTE THE BROKEN TIP FOUND DURING THE SET INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19552855 ↗MalfunctionAug 24, 2023Break; Fracture; Break; Fracture
A REPRESENTATIVE REPORTED THAT THE HUMERAL SIZE 3/4 IMPACTOR TIP BROKE AT THE END OF A SURGICAL CASE, BUT IT HAD NO IMPACT ON THE PATIENT OR THE SURGERY TIME. AN UPDATE PROVIDED ADDITIONAL DETAILS: THE LOT NUMBER WAS NOT VISIBLE ON THE BROKEN PIECE AFTER WASHING, THERE WAS NO DEBRIS THAT COULD HAVE FALLEN INTO THE PATIENT, THE ISSUE OCCURRED DURING A PRIMARY SURGERY, THE ITEM WAS IN SERVICE FOR APPROXIMATELY 1 YEAR, IT WAS NOT PART OF A LOANER KIT BUT A CONSIGNMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17611383 ↗MalfunctionJun 13, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE DEVICES WERE FOUND BROKEN AT SET INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17121902 ↗MalfunctionJun 13, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE DEVICES WERE FOUND BROKEN AT SET INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17121482 ↗MalfunctionNov 28, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE DURING SURGERY. IT IS UNKNOWN IF ANY DEBRIS WAS LEFT BEHIND IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15873328 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.