DJO SURGICAL 540-00-000Recalls & reported problems
Encore Medical, L.P. · DISC CONDYLE KIT W/ HEXALOBULA · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a DJO Surgical elbow prosthesis, a cemented implant with a disc condyle kit. The 63 reports mostly describe elbows that became unstable or loose, wore down, or cracked, and patients needing revision surgery; infections are also commonly mentioned. All 63 reports describe injuries and none describe deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 64
- Deaths reported
- 0
- Injuries reported
- 64
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00190446137610), received between Nov 15, 2019 and Sep 17, 2026 — classified as 64 injuries.
The most frequently reported specific device problem is “Unstable” (7 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 Problem34
- Appropriate Device Problem Term/Code Not Available18
- Unstable7
- Loose or Intermittent Connection5
- Naturally Worn3
- Device Dislodged or Dislocated2
- Fracture2
- Loosening of Implant Not Related to Bone-Ingrowth2
Patient problems
- Unspecified Infection24
- Joint Laxity17
- Insufficient Information14
- Failure of Implant3
- Pain3
- No Code Available2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Fall1
Recent adverse event reports
The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Device Dislodged or Dislocated
Patient problems: Unspecified Infection
MAUDE report 50812269 ↗InjurySep 15, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50781676 ↗InjuryJul 6, 2026Unstable
InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 23, 2026Unstable
InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
DR. B DID AN I & D AND BUSHING EXCHANGE.
Patient problems: Unspecified Infection
MAUDE report 24780621 ↗InjuryApr 1, 2026Unstable
InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - TOTAL ELBOW POLY EXCHANGE, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24310262 ↗InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
PATIENT HAS HAD SEVERAL SURGERIES. THE PATIENT CURRENTLY HAD IN AN ULNA IMPLANT. THE SURGEON HAD A CUSTOM HUMERUS IMPLANT MADE AND USED ALLOGRAFT, CEMENT, CABLES AND PLATE. THE SURGEON PUT CONDYLES IN TO LINK THE CUSTOM IMPLANT TO THE ULNA IMPLANT. SURGERY WAS COMPLETED AND SUCCESSFUL.
Patient problems: Insufficient Information
MAUDE report 23785760 ↗InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD A HUMERAL FRACTURE SO A NEW CONDYLE WAS PUT IN.
Patient problems: Limb Fracture
MAUDE report 23333905 ↗InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 30, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 20626797 ↗InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION AND LOOSENING.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 20615317 ↗InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO IMPLANT FAILURE.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 20529854 ↗InjuryAug 23, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO LOOSENING AND INFECTION.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 18044502 ↗InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
Other PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED devices
- 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
- Comprehensive® SRS / Discovery® 211253Biomet 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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