DJO SURGICAL 540-01-005Recalls & reported problems
Encore Medical, L.P. · DISC ULNA X-SMALL E+ BEARING KIT · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190446254560), received between Aug 19, 2021 and Jul 9, 2026 — classified as 3 injuries.
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
- Appropriate Device Problem Term/Code Not Available1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Naturally Worn1
- Patient Device Interaction Problem1
Patient problems
- Joint Laxity2
- Ambulation or Postural Difficulties1
- Metal Related Pathology1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 9, 2026Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - DUE TO THE BUSHING HAD WORN DOWN-AND METALLOSIS.
Patient problems: Joint Laxity; Metal Related Pathology
MAUDE report 25772734 ↗InjuryJan 6, 2026Patient Device Interaction Problem
InjuryAug 19, 2021Naturally Worn; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - SURGEON STATED THAT THE PATIENTS USE OF WALKER FOR AMBULATION LIKELY CAUSE OF BEARING WEAR.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 12345111 ↗
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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