DJO SURGICAL 130-03-729Recalls & reported problems
Encore Medical, L.P. · DOMED TRI-PEG PATELLA, 29x8mm, E-PLUS · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888912108522), received between Jan 10, 2019 and Aug 7, 2026 — classified as 11 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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 Problem8
- Appropriate Device Problem Term/Code Not Available1
- Detachment of Device or Device Component1
- Mechanical Problem1
- Naturally Worn1
Patient problems
- Fall3
- Insufficient Information2
- Joint Laxity2
- Unspecified Infection2
- Bone Fracture(s)1
- Failure of Implant1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 10, 2026Detachment of Device or Device Component
THE PATIENT EXPERIENCED A FALL IN WHICH THEIR PRESS-FIT PATELLA IMPLANT BECAME MEDIALLY DISLODGED. PURPOSE OF FOLLOW UP OPERATION WAS TO REMOVE THAT IMPLANT AND REPLACE WITH A CEMENTED PATELLA.
Patient problems: Failure of Implant
MAUDE report 25462925 ↗InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL AND BROKE THEIR PATELLA.
Patient problems: Fall; Insufficient Information
MAUDE report 19978773 ↗InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT FELL AND BROKE HER PATELLA. SURGEON HAD TO TAKE OUT THE PATELLA AND THE TIBIA INSERT.
Patient problems: Fall
MAUDE report 15589032 ↗InjuryJan 5, 2021Mechanical Problem
SECOND REVISION SURGERY - PATELLA TRACKING ISSUE AND POSSIBLE EXTENSOR MECHANISM AUGMENTATION.
Patient problems: Insufficient Information
MAUDE report 11120385 ↗InjuryAug 27, 2020Naturally Worn; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO POLY WEAR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10459978 ↗InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DISPLACED PATELLA FRACTURE, LOOSENING OF PATELLA IMPLANT.
Patient problems: Bone Fracture(s)
MAUDE report 8233542 ↗
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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