DJO SURGICAL 540-01-001Recalls & reported problems
Encore Medical, L.P. · DISC ULNA E+ BEARING KIT · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a DJO Surgical elbow prosthesis part, a disc ulna bearing kit used in total elbow replacement. The 53 reports mostly describe the implant loosening, becoming unstable or dislocating, wearing out, or infection, leading patients to have revision surgery on the elbow. There were no deaths, but 53 injuries. 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
- 55
- Deaths reported
- 0
- Injuries reported
- 55
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00190446254553), received between Jun 2, 2020 and Sep 15, 2026 — classified as 55 injuries.
The most frequently reported specific device problem is “Unstable” (5 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 Problem33
- Appropriate Device Problem Term/Code Not Available10
- Unstable5
- Degraded2
- Device Dislodged or Dislocated2
- Loose or Intermittent Connection2
- Loosening of Implant Not Related to Bone-Ingrowth2
- Naturally Worn2
Patient problems
- Joint Laxity17
- Insufficient Information12
- Unspecified Infection12
- Failure of Implant7
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Joint Dislocation2
- Fluid Discharge1
- Implant Pain1
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026No Apparent Adverse Event
Patient problems: Insufficient Information
MAUDE report 50782328 ↗InjurySep 15, 2026Loosening of Implant Not Related to Bone-Ingrowth
Patient problems: Joint Laxity; Metal Related Pathology
MAUDE report 50781681 ↗InjuryJun 11, 2026Unstable
InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 20, 2026Unstable
InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem
InjuryDec 19, 2025Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem
THE HUMERUS NEEDED A POST TRAUMATIC REVISION. IT WAS REVISED. THE NEW POLYETHYLENE IMPLANTS DID NOT FIT.
Patient problems: Insufficient Information
MAUDE report 23857984 ↗InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE HUMERUS NEEDED A POST TRAUMATIC REVISION. IT WAS REVISED. THE NEW POLYETHYLENE IMPLANTS DID NOT FIT.
Patient problems: Insufficient Information
MAUDE report 23857981 ↗InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - REVISION OF ULNAR AND BEARING COMPONENTS OF DISCOVERY ELBOW, UNKNOWN REASON
Patient problems: Insufficient Information
MAUDE report 23700714 ↗InjuryOct 28, 2025Degraded; Degraded
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY DUE TO POLY WEAR.
Patient problems: Failure of Implant
MAUDE report 23410554 ↗InjuryOct 21, 2025Degraded; Degraded
IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT A TOTAL ELBOW ARTHROPLASTY IN 2007. THE POLYETHYLENE COMPONENT HAD WORN OUT AND WAS SUBSEQUENTLY REPLACED ALONG WITH THE BEARING.
Patient problems: Insufficient Information
MAUDE report 23347026 ↗InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENTS POLY BEARING WAS WORN.
Patient problems: Joint Laxity
MAUDE report 22254198 ↗InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 7, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO ULNA RING FRACTURED.
Patient problems: Failure of Implant
MAUDE report 20153737 ↗InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RIVISION SURGERY - DUE TOFAILED POLY, BROKEN ULNAR EXTRACTOR, BROKEN POLY SWAP INSTRUMENTS.
Patient problems: Failure of Implant
MAUDE report 19621226 ↗InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO IMPLANT BROKE
Patient problems: Unspecified Infection
MAUDE report 19482491 ↗InjuryMay 13, 2024No Apparent Adverse Event; No Apparent Adverse Event
InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: DUE TO PAIN AND INFECTION.
Patient problems: Implant Pain; Unspecified Infection
MAUDE report 19177640 ↗InjuryMar 11, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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
- 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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