ATTUNE AFFIXIUMRecalls & reported problems across all models
Depuy Orthopaedics, Inc. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one ATTUNE AFFIXIUM model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 126
- Deaths reported
- 0
- Injuries reported
- 119
- Recalls
- 1
We found 9 models of ATTUNE AFFIXIUM by Depuy Orthopaedics, Inc. in the FDA's device registry (GUDID). Together they are named in 126 adverse event reports in the FDA's MAUDE database, received between Dec 1, 2022 and Sep 29, 2026 — classified as 119 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Osseointegration Problem” (28 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
ATTUNE AFFIXIUM recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 12, 2024Open, Classified
Product incorrectly labelled.
Z-1456-2024 · Root cause: Process change control · Recall details · FDA record ↗
Most reported ATTUNE AFFIXIUM problems
Device problems
- Adverse Event Without Identified Device or Use Problem61
- Osseointegration Problem28
- Migration20
- Loss of or Failure to Bond7
- Use of Device Problem7
- Wrong Label5
- Manufacturing, Packaging or Shipping Problem3
- Fracture2
Patient problems
- Pain33
- Unspecified Infection33
- Inadequate Osseointegration26
- Insufficient Information20
- Joint Laxity13
- Fall6
- No Clinical Signs, Symptoms or Conditions6
- Bone Fracture(s)3
ATTUNE AFFIXIUM models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ATTUNE AFFIXIUM 1506-21-006PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall31 reports
- ATTUNE AFFIXIUM 1506-21-007PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER25 reports
- ATTUNE AFFIXIUM 1506-21-005PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER24 reports
- ATTUNE AFFIXIUM 1506-21-004PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER19 reports
- ATTUNE AFFIXIUM 1506-21-008PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER12 reports
- ATTUNE AFFIXIUM 1506-21-003PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER11 reports
- ATTUNE AFFIXIUM 1506-21-009PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- ATTUNE AFFIXIUM 1506-21-001PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- ATTUNE AFFIXIUM 1506-21-010PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
Recent ATTUNE AFFIXIUM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Osseointegration Problem
It was reported that Surgeon revised tibia. Tibia was loose and loosening interface was bone to implant (Non-Cemented).Affected Side: Left knee.
Patient problems: Inadequate Osseointegration
MAUDE report 50934712 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50915293 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient was revised due to pain. No loosening, nothing further to report.Affected Side: Left Knee.
Patient problems: Pain
MAUDE report 50913621 ↗InjurySep 28, 2026Migration
It was reported that the patient fell one day after these were implanted. The tibia subsided.Affected side: Right.
Patient problems: Fall
MAUDE report 50913539 ↗InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient fell after original total knee arthroplasty, followed by a broken patella, surgical fixation of the patella, development of infection, and removal and replacement of all components except the patella was done. A SureSpace spacer was implanted. DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected Side: Left Knee.
Patient problems: Fall; Unspecified Infection
MAUDE report 50310796 ↗InjuryAug 7, 2026Use of Device Problem
Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. Darthmouth is the research location, and not the facility of placement.A DePuy Synthes Implant was revised and reviewed for analysisReason for revision: Revision due to malpositioning of unknown component(s) and pain.
Patient problems: Pain
MAUDE report 50180130 ↗InjuryAug 3, 2026Loss of or Failure to Bond
Patient problems: Insufficient Information
MAUDE report 50117827 ↗InjuryJul 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT.
Patient problems: Unspecified Infection
MAUDE report 25903771 ↗InjuryJun 8, 2026Osseointegration Problem
IT WAS REPORTED THAT PATIENT REPORTS A PAINFUL TKA. ALL LABS NORMAL. SURGEON REMOVED TIBIAL INSERT AND TRAY. SAYS THE TRAY SHOWED EVIDENCE OF "PARTIAL INGROWTH." REPLACED WITH A CEMENTED FB REV TRAY. IT WAS STATED THAT TIBIAL COMPONENT WAS LOOSE. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 25431733 ↗InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DUE TO THE FEMORAL COMPONENT DISLODGING AND ROTATING ANTERIORLY, THE KNEE WAS REVISED IN ITS ENTIRETY. THE FEMORAL COMPONENT, TIBIAL COMPONENT AS WELL AS POLY INSERT WERE REMOVED FROM THE PT. AND FIELD, THERE WAS NO DELAY TO THE CASE NOR HARM DONE TO THE PATIENT. THERE WAS AN ATTEMPT TO SALVAGE THE PRIMARY CONSTRUCT, BUT THERE WAS NO WAY TO RECONSTRUCT THE FEMUR PROPERLY. AFFECTED SIDE- RIGHT KNEE.
Patient problems: Joint Laxity
MAUDE report 25394908 ↗InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO FALLING AFTER TOTAL KNEE REPLACEMENT. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.
Patient problems: Fall
MAUDE report 25354687 ↗InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT EXPRESSED DISCOMFORT AND PAIN IN THE TIBIA. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOI: (B)(6) 2025. DOR: UNKNOWN. AFFECTED SIDE: LEFT KNEE.
Patient problems: Discomfort; Pain
MAUDE report 25190986 ↗InjuryMay 5, 2026Osseointegration Problem
SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ ASEPTIC LOOSENING. DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: (B)(6) 2026. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: (B)(6) 2026. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: REVISION. DEPUY SYNTHES PRODUCTS USED. CATALOG NUMBER: 150401104. LOT NUMBER: 3793392.. COMPONENT TYPE: FEMORAL DESCRIPTION: ATTUNE CR FEM LT SZ 4 POR. CATALOG NUMBER: 150621004. LOT NUMBER: JA04A0460. COMPONENT TYPE: TIBIAL. DESCRIPTION: ATTUNE FB TIB BASE SZ 4 POR. CATALOG NUMBER: 151820406. LOT NUMBER: M83K02. COMPONENT TYPE: INSERT. DESCRIPTION: ATTUNE LEFT MEDIAL STABILIZED INSERT SIZE 4 6MM. CATALOG NUMBER: 151810035 LOT NUMBER: 4689234. COMPONENT TYPE: PATEL.AR. DESCRIPTION: ATTUNE MEDIAL ANAT PAT 35MM. CATALOG NUMBER: 3322020. LOT NUMBER: 4494872. COMPONENT TYPE: PATELLAR. DESCRIPTION: SMART SET BONE CEMENT 20G.
Patient problems: Inadequate Osseointegration
MAUDE report 25081152 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ PAIN/STIFFNESS. DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: (B)(6) 2026. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: (B)(6) 2026. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL). DEPUY SYNTHES PRODUCTS USED. CATALOG NUMBER: 150401206. LOT NUMBER: 4035479. COMPONENT TYPE: FEMORAL. DESCRIPTION: ATTUNE CR FEM RT SZ 6 POR. CATALOG NUMBER: 150621006. LOT NUMBER: JA06A1468. COMPONENT TYPE: TIBIAL. DESCRIPTION: ATTUNE FB TIB BASE SZ 6 POR. CATALOG NUMBER: 152020606. LOT NUMBER: M5345X. COMPONENT TYPE: INSERT. DESCRIPTION: ATTUNE RIGHT MEDIAL STABILIZED INSERT SIZE 6 6MM. CATALOG NUMBER: 3322020. LOT NUMBER: 4513647. COMPONENT TYPE: CEMENT. DESCRIPTION: SMART SET BONE CEMENT 20G.
Patient problems: Muscular Rigidity; Pain
MAUDE report 25045196 ↗InjuryApr 28, 2026Migration
IT WAS REPORTED THAT ATTUNE PRESSFIT TIBIA WAS REMOVED DUE TO MEDIAL SIDE SUBSIDING. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Insufficient Information
MAUDE report 25019172 ↗
Other Depuy Orthopaedics, Inc. products
- PINNACLE ALTRX98 models · 5,631 reports
- BIOLOX DELTA40 models · 4,995 reports · 1 recall
- PINNACLE182 models · 4,587 reports
- QUICKSET7 models · 3,790 reports
- PINNACLE POROCOAT38 models · 2,112 reports
- SUMMIT POROCOAT20 models · 1,646 reports
- PINNACLE GRIPTION57 models · 1,608 reports
- DURALOC93 models · 1,262 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 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