DJO SURGICAL 540-45-100Recalls & reported problems
Encore Medical, L.P. · DISC HUM 5X100MM RT FLANGED C · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00190446137849), received between Apr 18, 2022 and Aug 25, 2025 — classified as 10 injuries.
The most frequently reported specific device problem is “Fracture” (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
- Adverse Event Without Identified Device or Use Problem8
- Appropriate Device Problem Term/Code Not Available1
- Fracture1
- Loose or Intermittent Connection1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Failure of Implant2
- Bone Fracture(s)1
- Implant Pain1
- Insufficient Information1
- Joint Dislocation1
- Joint Laxity1
- Limb Fracture1
- Loss of Range of Motion1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
COMPLAINT: BROKEN HUMERUS. NEEDED LONGER HUMERAL COMPONENT.
Patient problems: Failure of Implant
MAUDE report 22891753 ↗InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO UNKNOWN REVISION REASON.
Patient problems: Insufficient Information
MAUDE report 21063872 ↗InjuryNov 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT WAS EXPERIENCING PAIN.
Patient problems: Implant Pain
MAUDE report 20701569 ↗InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO STIFFNESS.
Patient problems: Loss of Range of Motion
MAUDE report 19218427 ↗InjuryApr 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 21, 2022Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY ULNA & HUMERUS BECAME LOOSE & SURGEON REPLACED. PATIENT ALSO HAD A PERI PROSTHETIC FRACTURE.
Patient problems: Bone Fracture(s); Failure of Implant
MAUDE report 15077198 ↗InjuryApr 18, 2022Fracture; Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DISTAL HUMERAL FRACTURE AND HARDWARE LOOSENING. ELBOW PAIN.
Patient problems: Pain
MAUDE report 14137576 ↗
Other PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED devices
- DJO SURGICAL 540-00-000Encore Medical, L.P. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED64 reports
- Arcos Modular Revision Hip System 11-301321Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall7 reports
- DJO SURGICAL 540-01-001Encore Medical, L.P. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED55 reports
- Arcos Modular Revision Hip System 11-301302Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall5 reports
- Arcos Modular Revision Hip System 11-301343Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall1 report
- ARROW IPN037140Teleflex Incorporated · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 reports
- Comprehensive® SRS / Discovery® 211251Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 reports
- Arcos Modular Revision Hip System 11-301325Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 reports
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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