DJO SURGICAL 130-03-732Recalls & reported problems
Encore Medical, L.P. · DOMED TRI-PEG PATELLA, 32x8mm, E-PLUS · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Encore Medical domed tri-peg patella implant is used to resurface the kneecap during total knee replacement surgery. The 27 reports describe infection, kneecap instability, looseness and pain, with several patients needing a second operation; the latest reports mention revision surgery for infection and a fall that fractured the patella. All 27 reports involve injuries, and no deaths were reported. No recalls name 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
- 27
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00888912108539), received between Jun 5, 2018 and Aug 27, 2026 — classified as 27 injuries.
The most frequently reported specific device problem is “Unstable” (4 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 Problem14
- Appropriate Device Problem Term/Code Not Available8
- Unstable4
- Loose or Intermittent Connection2
- Device Dislodged or Dislocated1
- Device Slipped1
- Fracture1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Unspecified Infection9
- Insufficient Information5
- Joint Laxity5
- Fall3
- No Code Available3
- Pain3
- Bone Fracture(s)1
- Implant Pain1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026No Apparent Adverse Event
Revision surgery - Due to unknown revision reason / Poly Swap.
Patient problems: Insufficient Information
MAUDE report 50465514 ↗InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - FOR PATELLA RESURFACING, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24173034 ↗InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL POST OPERATIVELY AND FRACTURE PATELLA.
Patient problems: Fall
MAUDE report 22974265 ↗InjuryMar 27, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryAug 13, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INSTABILITY AND INFECTION.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 19978775 ↗InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 16, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INSTABILITY AND INFECTION.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 17561280 ↗InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT'S PATELLA WASN'T TRACKING PROPERLY.
Patient problems: Joint Laxity
MAUDE report 17484568 ↗InjuryApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 31, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PATIENT FELL AND CAUSED THE PATELLA IMPLANT TO LOOSEN. A BIGGER PATELLA WAS PUT IT IN PLACE.
Patient problems: Fall
MAUDE report 13969336 ↗InjuryFeb 16, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: PATIENT COMPLAINED OF PAIN AND SUSPECTED INFECTION.
Patient problems: Pain; Unspecified Infection
MAUDE report 13542099 ↗InjuryOct 20, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO DISPLACED PATELLA BY FALLING.
Patient problems: Fall
MAUDE report 12666771 ↗InjuryJul 13, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - POSSIBLE INFECTION, POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 12159675 ↗InjuryMay 20, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATELLA COMPONENT LIT UP ON A BONE SCAN.
Patient problems: Insufficient Information
MAUDE report 11858442 ↗InjuryMar 26, 2021Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT FELT A POP DURING THERAPY AND WAITED OVER A YEAR TO SEEK MEDICAL TREATMENT. IT WAS DISCOVERED THAT PART OF HER SUPERIOR PATELLA HAD FRACTURED BUT THE IMPLANTED PATELLA WAS STILL INTACT AND THE BONE UNDER THE PATELLA WAS INTACT.
Patient problems: Insufficient Information
MAUDE report 11575350 ↗InjuryOct 16, 2020Unstable; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 10691488 ↗InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem
InjuryApr 2, 2020Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - DUE TO LOOSENING OF THE PATELLA.
Patient problems: No Code Available
MAUDE report 9917239 ↗InjuryJan 3, 2020Patient-Device Incompatibility
REVISION SURGERY - PATIENT COMPLAINED OF PAINFUL KNEE.
Patient problems: No Code Available; Pain
MAUDE report 9547444 ↗InjuryOct 18, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT ACQUIRED AN POST-OPERATIVE INFECTION. SURGEON PERFORMED A RESECTION AND PLACED A ANTIBIOTIC ARTICULATING SPACER.
Patient problems: Unspecified Infection
MAUDE report 9208398 ↗
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 + additive/metal/polymer + additive devices
- iTotal® PS TPS111111102Conformis, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive327 reports
- ATTUNE 1506-00-006Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive287 reports
- ATTUNE 1506-00-008Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive233 reports
- iTotal® Cruciate Retaining (CR) Knee Replacement System TCR121111102Conformis, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive150 reports
- ATTUNE 1506-70-007Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 recall2 deaths74 reports
- ATTUNE 1516-40-506Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive121 reports
- ATTUNE 1506-70-006Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 recall70 reports
- ATTUNE 1516-40-605Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive120 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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