Tornier Perform Humeral System PFX00120Recalls & reported problems
Tornier, Inc. · Fracture Stem Screw · Class 2 · Implant
All models of TORNIER PERFORM HUMERAL SYSTEM (68)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00846832093410), received between Jun 19, 2026 and Jun 19, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Loss of Range of Motion1
- Post Operative Wound Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 19, 2026Loosening of Implant Not Related to Bone-Ingrowth
THE PATIENT SUSTAINED A PROXIMAL HUMERUS FRACTURE THAT WAS TREATED WITH TUBEROSITY REPAIR AND HEMIARTHROPLASTY. AT THE TIME OF THE PROCEDURE, THE ROTATOR CUFF WAS CONFIRMED TO BE INTACT. FOLLOWING SURGERY, THE PATIENT WAS REPORTEDLY NON-COMPLIANT WITH SLING USE AND NON-WEIGHT-BEARING RESTRICTIONS, RESULTING IN FAILURE OF THE FRACTURE REPAIR. THE PATIENT DID NOT RETURN FOR FOLLOW-UP UNTIL A LATER DATE, AT WHICH TIME CONCERNS REGARDING THE OUTCOME OF THE REPAIR WERE IDENTIFIED. FOLLOWING POSITIVE CULTURE RESULTS, THE PATIENT REQUESTED REMOVAL OF THE HEMIARTHROPLASTY AND PLACEMENT OF AN ANTIBIOTIC SPACER. THE SURGEON EXPLAINED THE ANTICIPATED FUNCTIONAL LIMITATIONS ASSOCIATED WITH REMOVAL OF THE IMPLANT; HOWEVER, THE PATIENT ELECTED TO PROCEED WITH EXPLANTATION. THE HEMIARTHROPLASTY WAS REMOVED AND REPLACED WITH AN ANTIBIOTIC SPACER.
Patient problems: Loss of Range of Motion; Post Operative Wound Infection
MAUDE report 25563263 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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