DISCOVERY ELBOW SYSTEM 114909Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304215795), received between Feb 10, 2021 and Feb 25, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Failure of Implant1
- Joint Dislocation1
- Joint Laxity1
- Loss of Range of Motion1
- No Known Impact Or Consequence To Patient1
- Pain1
- Paresthesia1
- Swelling/ Edema1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT THE IMPLANTATION OF A ZB TOTAL ELBOW ARTHROPLASTY APPROXIMATELY EIGHT (8) YEARS AGO. PATIENT PREVIOUSLY HAD FALLEN OFF OF A LADDER AND RECEIVED A COMPETITOR'S RADIAL HEAD REPLACEMENT; HOWEVER, THE PATIENT LATER REQUIRED ULNAR NEUROLYSIS AND ANTEPOSITION, REMOVAL OF THE COMPETITOR RADIAL HEAD PROSTHESIS, REMOVAL OF RADIO-ULNAR SYNOSTOSIS, AND REMOVAL OF HETEROTOPIC CALCIFICATIONS DUE TO IMPLANT SUBLUXATION AND RADIAL NERVE DAMAGE. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL FOR YEARS FOLLOWING THEIR IMPLANTATION OF THE ZB ELBOW. SUBSEQUENTLY, APPROXIMATELY SEVEN (7) YEARS POST-IMPLANTATION OF THE ZB ELBOW, THE PATIENT WAS WALKING AND EXPERIENCED A SUDDEN INTENSE PAIN IN THE ELBOW WITHOUT ASSOCIATED TRAUMA. X-RAYS SHOWED IMPLANT FRACTURE OF THE ULNAR COMPONENT AND DISLOCATION. REVISION SURGERY HAS BEEN RECOMMENDED BUT NOT YET SCHEDULED, AND PATIENT IS CONTINUING TO EXPERIENCE PAIN, SWELLING, PARESTHESIA AND LIMITED MOTION IN THE JOINT AND USING A BRACE UNTIL THE REVISION OCCURS. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. AS NO ADDITIONAL INFORMATION OR PRODUCT IS AVAILABLE, WE
Patient problems: Failure of Implant; Joint Dislocation; Joint Laxity; Loss of Range of Motion; Pain; Paresthesia; Swelling/ Edema
MAUDE report 21459642 ↗InjuryFeb 10, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY FIVE YEARS POST INITIAL IMPLANTATION DUE TO THE LOOSENING OF THE HUMERAL COMPONENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 11309590 ↗
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
- Bearing and Axle Bushing Assembly - Standard Elbow C-M113-1-301Howmedica Osteonics Corp. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 reports
- Comprehensive® SRS / Discovery® 211251Biomet 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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