ATTUNE 1520-20-507Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM TIBIAL INSERT FIXED BEARING MEDIAL STABILIZED RIGHT AOX 5, 7mm · Class 2 · Implant
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295542506), received between Dec 11, 2023 and Apr 3, 2026 — classified as 6 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- Device Dislodged or Dislocated1
Patient problems
- Joint Laxity2
- Fall1
- Insufficient Information1
- Unspecified Infection1
- Unspecified Tissue Injury1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD POLY SWAP FOR LAXITY IN THE KNEE. AFFECTED SIDE- RIGHT KNEE.
Patient problems: Joint Laxity
MAUDE report 24782214 ↗InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT TORE LATERAL RETINACULUM. THE SURGEON REMOVED OLD POLY AND IMPLANTED NEW POLY. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.
Patient problems: Unspecified Tissue Injury
MAUDE report 24758466 ↗InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT POLY SWAPPED DURING A KNEE WASHOUT. INFECTION PREVENTION. AFFECTED SIDE-RIGHT KNEE.
Patient problems: Insufficient Information
MAUDE report 24233235 ↗InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Joint Laxity
MAUDE report 23348256 ↗InjuryJul 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT FELL AND DISLOCATED, AND THE SURGEON REMOVED THE OLD INSERT AND PUT IN A THICKER ONE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.
Patient problems: Fall
MAUDE report 19724114 ↗InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT GOT WATER UNDERNEATH THEIR DRESSING. DEVELOPED SUPERFICIAL INFECTION. I&D POLY SWAP WAS PERFORMED. DOI: (B)(6), 2023. DOR: (B)(6), 2023. AFFECTED SIDE: UNKNOWN KNEE.
Patient problems: Unspecified Infection
MAUDE report 18302604 ↗
Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices
- ATTUNE 1512-14-050Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER106 reports
- ATTUNE 1504-40-205Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall53 reports
- ATTUNE 1504-40-105Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall46 reports
- ATTUNE 1547-06-001Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall37 reports
- ATTUNE 1513-12-060Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER72 reports
- Triathlon 5521-B-300Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- Triathlon 5531-G-709-EHowmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- ATTUNE 1512-16-080Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall16 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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