DJO SURGICAL 130-03-735Recalls & reported problems
Encore Medical, L.P. · DOMED TRI-PEG PATELLA, 35x9mm, E-PLUS · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a DJO Surgical domed tri-peg patellar implant used in knee replacement surgery. The 28 reports describe kneecap components that break or fracture, or that sit loosely and let the kneecap slip out of its groove, along with infection, pain, and instability — several patients needed revision surgery because the pegs sheared off and the kneecap became loose in the knee. No deaths were reported; all 28 reports involved injuries. There are no recalls naming 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
- 28
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00888912108553), received between Nov 14, 2017 and Apr 6, 2026 — classified as 28 injuries.
The most frequently reported specific device problem is “Break” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K113756); 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 Problem16
- Appropriate Device Problem Term/Code Not Available6
- Break2
- Fracture2
- Loose or Intermittent Connection2
- Unstable2
- Device Fell1
- Patient Device Interaction Problem1
Patient problems
- Joint Laxity7
- Insufficient Information5
- Failure of Implant4
- Pain4
- Unspecified Infection4
- Bone Fracture(s)2
- Fall2
- Implant Pain2
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjuryApr 6, 2026Unstable
InjuryFeb 23, 2026Patient Device Interaction Problem
REVISION SURGERY - DUE TO SECONDARY PATELLA REPLACEMENT WITH EMPOWER LYING DOWN, OPERATED ON DATE DUE TO FEMOROPATELLAR HYPERPRESSURE. PERSISTENT PAIN WITH DISTURBED SLEEP AND INABILITY TO BEAR WEIGHT IN EVERYDAY LIFE.
Patient problems: Pain
MAUDE report 24424210 ↗InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem
InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO POLY SWAP /PATELLA MAL-TRACKING.
Patient problems: Insufficient Information
MAUDE report 21947121 ↗InjuryMar 13, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: DUE TO PATELLA PEGS SHEERED OF PATELLA AND PATELLA BECAME LOOSE IN KNEE.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 21579862 ↗InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO RESURFACED AN UNRESURFACED PATELLA.
Patient problems: Insufficient Information; Joint Laxity
MAUDE report 18966137 ↗InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAD HUGE HEMATOMA WITH RETICULAR TEAR.
Patient problems: Insufficient Information
MAUDE report 17936633 ↗InjuryAug 1, 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 17438674 ↗InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATELLA REVISION SCAR REVISION.
Patient problems: Insufficient Information
MAUDE report 16865758 ↗InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 25, 2022Break; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT FELL, BROKE PATELLAR COMPONENT, REVISED PATELLA AND PUT A NEW LINER IN.
Patient problems: Fall
MAUDE report 15099506 ↗InjuryJun 9, 2022Break; Loose or Intermittent Connection
REVISION SURGERY - PATIENT NOTICED CREPITUS AND PAIN AFTER INITIAL SURGERY. X RAY REVEALED WHAT APPEARED TO BE A LOOSE PATELLA. REVISION SURGERY WAS PERFORMED AND IT WAS DETERMINED THAT THE PEGS CROKE OFF OF THE BACKSIDE OF THE PATELLA. THE ORIGINAL PATELLA AND PEGS WERE REMOVED AND A NEW PATELLA BUTTON WAS PLACED. POLY SPACER WAS ALSO REPLACED, HOWEVER THERE WAS NO ISSUE WITH POLY SPACER.
Patient problems: Failure of Implant; Pain
MAUDE report 14645936 ↗InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY, DUE TO POST OPERATIVE INFECTED TOTAL KNEE REMOVAL.
Patient problems: Unspecified Infection
MAUDE report 14250928 ↗InjuryFeb 10, 2022Appropriate Device Problem Term/Code Not Available; Device Fell
InjuryFeb 1, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY : SURGEON REVISED A DJO KNEE. HE CUT 5MM OF ADDITIONAL PATELLA BONE & RE/RESURFACED THE PATELLA. HE ALSO ADDED 2MM OF ADDITIONAL PE FOR THE TIBIAL INSERT.
Patient problems: Insufficient Information
MAUDE report 13418179 ↗InjuryMay 6, 2021Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PATIENT PRESENTED TO REVISING SURGEON WITH A FRACTURED PATELLA.
Patient problems: Failure of Implant
MAUDE report 11782862 ↗InjuryJan 15, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO SWITCHED FROM EMPOWR TO EPIC.
Patient problems: No Code Available
MAUDE report 9593448 ↗InjuryDec 23, 2019Patient-Device Incompatibility
InjuryOct 23, 2019Appropriate Device Problem Term/Code Not Available
Recalls under the same FDA submission
These recalls involve devices cleared under K113756. One submission often covers many models, so check the product and lot details in each record.
- Z-0626-2024 · Oct 5, 2023 · CompletedREF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2
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
- 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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