DJO SURGICAL 540-44-100Recalls & reported problems
Encore Medical, L.P. · DISC HUM 4X100MM RT FLANGED C · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00190446137832), received between Jul 15, 2021 and Jun 10, 2026 — classified as 20 injuries.
The most frequently reported specific device problem is “Fracture” (2 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem14
- Fracture2
- Appropriate Device Problem Term/Code Not Available1
- Device Dislodged or Dislocated1
- Loosening of Implant Not Related to Bone-Ingrowth1
- No Apparent Adverse Event1
Patient problems
- Joint Laxity10
- Bone Fracture(s)5
- Failure of Implant2
- Implant Pain2
- Limb Fracture2
- Fall1
- Insufficient Information1
- Pain1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2026Fracture
InjuryOct 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY DUE TO LOOSE IMPLANTS CAUSING PATIENT PAIN.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 23353612 ↗InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FRACTURE.
Patient problems: Bone Fracture(s); Limb Fracture
MAUDE report 19757640 ↗InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN AND FRACTURE.
Patient problems: Implant Pain; Limb Fracture
MAUDE report 18531783 ↗InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - IMPLANT LOOSENING ON HUMERAL COMPONENT.
Patient problems: Joint Laxity
MAUDE report 16677917 ↗InjuryMar 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 7, 2023No Apparent Adverse Event; No Apparent Adverse Event
REVISION SURGERY - DUE TO HUMERAL COMPONENT AS WELL CONDYLE KIT WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 16315501 ↗InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FRACTURE AND TRAUMA.
Patient problems: Bone Fracture(s)
MAUDE report 15563981 ↗InjuryDec 16, 2021Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - DUE TO ELBOW PAIN AND LOOSENING OF HUMERAL COMPONENT.
Patient problems: Pain
MAUDE report 13018329 ↗InjuryDec 10, 2021Fracture
REVISION SURGERY - DUE TO PATIENT FALLING RESULTING IN FRACTURE. REQUIRING REVISION OF COMPONENTS TO FIX FRACTURE AND RE-IMPLANTING.
Patient problems: Bone Fracture(s); Fall
MAUDE report 12976175 ↗InjuryJul 15, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - HUMERAL COMPONENT PERFORATED HUMERUS. REVISED TO A 5X150MM HUMERAL COMPONENT.
Patient problems: Failure of Implant; Perforation
MAUDE report 12177068 ↗
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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