DJO SURGICAL 130-03-738Recalls & reported problems
Encore Medical, L.P. · DOMED TRI-PEG PATELLA, 38x9mm, E-PLUS · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00888912108560), received between Nov 1, 2018 and Jul 28, 2025 — classified as 21 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Oct 5, 2023Class IICompleted
Mislabeling
Z-0626-2024 · Root cause: Packaging process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem12
- Appropriate Device Problem Term/Code Not Available4
- Loosening of Implant Not Related to Bone-Ingrowth2
- Break1
- Loose or Intermittent Connection1
- Therapeutic or Diagnostic Output Failure1
- Unstable1
Patient problems
- Joint Laxity6
- Failure of Implant4
- Unspecified Infection4
- Fall2
- Implant Pain2
- Insufficient Information2
- Pain2
- Discomfort1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATELLA FRACTURE.
Patient problems: Failure of Implant
MAUDE report 21360807 ↗InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO IMPLANT BROKE, PEGS ON PATELLA BROKE AND WERE FLOATING.
Patient problems: Failure of Implant
MAUDE report 20518619 ↗InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATELLA SHOWED UP ON THE BONE SCAN. 74 YR OLD MALE.
Patient problems: Insufficient Information
MAUDE report 18522864 ↗InjurySep 5, 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: Joint Laxity; Limb Fracture
MAUDE report 17687363 ↗InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE INFECTION AND FRACTURE.
Patient problems: Muscle/Tendon Damage; Unspecified Infection
MAUDE report 17592672 ↗InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT COMPLAINED ABOUT PAIN, SO HIS PATELLA WAS REMOVED, AND THIS IMPLANT WAS ADDED.
Patient problems: Pain
MAUDE report 15801364 ↗InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT PRESENTED TO SURGEON WITH RIGHT KNEE PAIN. ON X-RAY IT APPEARED THAT THE PATELLA IMPLANT WAS LOOSE AND HAD DISASSOCIATED FROM THE BONE. IN THE REVISION SURGERY, IT WAS CONFIRMED THAT THE PATELLA HAD COME LOOSE, AND APPEARED THAT THE PEGS ON THE PATELLA IMPLANT HAD SHEARED OFF. PRIOR BONE CEMENT WAS ON THE IMPLANT BUT DID NOT APPEAR ON THE NATIVE PATELLA. SURGEON SPECULATED THAT POSSIBLY IN THE PRIMARY SURGERY BONE CEMENT HAD SETUP QUICKLY AND PERHAPS DID NOT GET STRONG ADHERENCE TO THE BONE. PRE-REVISION X-RAYS AND INTRA-OPERATIVE PICTURES ATTACHED.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 15341572 ↗InjuryAug 3, 2022Therapeutic or Diagnostic Output Failure
REVISION SURGERY - PATIENT NEEDED PATELLA.
Patient problems: Failure of Implant
MAUDE report 15157184 ↗InjuryMar 24, 2022Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - LOOSE KNEE AND PAIN, PATELLA WAS LOOSE. NO KNOWN TRAUMA.
Patient problems: Joint Laxity; Pain
MAUDE report 13876460 ↗InjuryNov 1, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO CHRONICALLY INFECTED KNEE. PRIMARY TOTAL KNEE ARTHROPLASTY IMPLANTS WERE REMOVED AND REPLACED WITH AN OSTEOREMEDIES ANTIBIOTIC SPACER WAS USED IN THE FIRST STAGE OF THE REVISION. THE REPRESENTATIVE WAS NOT NOTIFIED OR PRESENT FOR THE REMOVAL OF THESE IMPLANTS. LATER THE REPRESENTATIVE WAS PRESENT FOR THE 2ND STAGE OF THE REVISION (REMOVAL OF ANTIBIOTIC SPACER AND IMPLANTATION OF REVISION KNEE SYSTEM), USING EXPRT KNEE AND FOUND OUT THAT THIS PATIENT PREVIOUSLY HAD A KNEE THAT WAS REMOVED.
Patient problems: Unspecified Infection
MAUDE report 12733915 ↗InjuryOct 20, 2021Appropriate Device Problem Term/Code Not Available
InjuryMay 17, 2021Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - THE PATIENT HAD A LOOSE PATELLA BUTTON.
Patient problems: Insufficient Information
MAUDE report 11832659 ↗InjuryMay 2, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PATIENT WAS INFECTED. ALL COMPONENTS WERE REMOVED.
Patient problems: Unspecified Infection
MAUDE report 11758779 ↗InjuryMay 26, 2020Break
REVISION SURGERY - THE PATIENT HAD AN AGGRESSIVE FALL AND IT SHEERED THE PATELLA.
Patient problems: Failure of Implant; Fall
MAUDE report 10087673 ↗InjuryDec 5, 2018Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT HAVING DISCOMFORT.
Patient problems: Discomfort
MAUDE report 8134877 ↗InjuryDec 4, 2018Unstable
REVISION SURGERY - DUE TO INSTABILITY AND QUADRICEPS REPAIR. THE SURGEON REMOVED AND EXCHANGED OUT THE INSERT. TOWARDS THE END, THE INSERT WAS NOT BIG ENOUGH, SO THE NEW INSERT WAS REMOVED ALONG WITH ALL ORIGINAL DJO IMPLANTS AND REPLACED WITH COMPETITOR BRAND IMPLANTS.
Patient problems: No Code Available
MAUDE report 8129205 ↗InjuryNov 1, 2018Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE PATIENT FALLING AND HAVING A LOOSE PATELLA.
Patient problems: Fall
MAUDE report 8029280 ↗
Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page