DJO SURGICAL 540-53-115Recalls & reported problems
Encore Medical, L.P. · DISC ULNA 3X115MM LT W/ E+ BRNG · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00190446254393), received between Jan 12, 2022 and Jul 8, 2026 — classified as 7 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K013042); they may or may not involve this specific model.
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 Problem5
- Insufficient Device Problem Information1
- No Apparent Adverse Event1
Patient problems
- Failure of Implant3
- Bone Fracture(s)2
- Joint Laxity2
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2026No Apparent Adverse Event
REVISION SURGERY - IMPLANT WAS MISSING. ULNA COMPONENT REMOVED FROM PATIENT PRIOR AT A DIFFERENT HOSPITAL. REVISION CASE WAS SCHEDULED TO IMPLANT NEW ULNA COMPONENT.
Patient problems: Insufficient Information
MAUDE report 25755502 ↗InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO STEM BROKE, PIECES LEFT IN PATIENT.
Patient problems: Failure of Implant; Foreign Body In Patient
MAUDE report 21568984 ↗InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO IMPLANT FAILED.
Patient problems: Failure of Implant
MAUDE report 17804362 ↗InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FRACTURE AND LOOSENING.
Patient problems: Bone Fracture(s); Joint Laxity
MAUDE report 17140231 ↗InjuryJan 12, 2022Insufficient Device Problem Information
REVISION SURGERY - DUE TO IMPLANT CAME OUT OF BONE.
Patient problems: Failure of Implant
MAUDE report 13237926 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K013042. One submission often covers many models, so check the product and lot details in each record.
- Z-1925-2014 · May 15, 2014 · TerminatedDISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intended for primary and revi
- Z-0033-2009 · May 23, 2008 · TerminatedBiomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; R
- Z-0032-2009 · May 23, 2008 · TerminatedBiomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; RE
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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