ATTUNE 1516-50-807Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10603295052869), received between Sep 15, 2017 and Jun 8, 2026 — classified as 46 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS TWO WEEKS OUT FROM A TKR. PATIENT TRIPPED AND FELL DIRECTLY ON TKR INCISION AND BROKE OPEN THE WOUND. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 25428943 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: DOI (B)(6) 2017: MALE PATIENT RECEIVED A LEFT DEPUY ATTUNE PRIMARY KNEE TO TREAT SEVERE DJD. THE PATELLA WAS NOT RESURFACED, AND THE FEMORAL AND TIBIAL COMPONENTS WERE IMPLANTED WITH DEPUY SMARTSET CEMENT X2. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PART/LOT INFORMATION IS PROVIDED ON PP.5-6. DOR (B)(6) 2022: 58-YEAR-OLD MALE PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT CHRONIC PAIN, INSTABILITY, AND WALKING DIFFICULTY SECONDARY TO FEMORAL OSTEOLYSIS AND LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND DEBRIDED FEMORAL OSTEOLYSIS AND ABUNDANT FEMORAL OSTEOPHYTES. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REMOVED. FEMORAL OSTEOLYSIS WAS CURETTED WHEN THE FEMORAL COMPONENT WAS REMOVED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATIENT RECEIVED A COMPETITOR CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE POSTOPERATIVE SWELLING AND VENOUS DOPPLER NOTED ON (B)(6) 2022 WAS RELATED TO THE COMPETITOR KNEE AND NOT ASSOCIATED WITH A DEPUY DEVICE OR PROCEDURE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 23540964 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S SOFT TISSUES RELAXED AND HIS GAPS EXPANDED. SURGEON HAD TO PUT IN A THICKER POLY. AFFECTED SIDE - RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 23019623 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT INSERT WAS REVISED DUE TO LIMITATION RANGE OF MOTION. REVISED TO THINNER INSERT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 22531673 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO DELAYS IN SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 20577348 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR SEPSIS. DEVICE RELATEDNESS: NO INFORMATION PROVIDED. PROCEDURE RELATEDNESS: NO INFORMATION PROVIDED. DATE OF EVENT: UNK DEC 2024. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION : NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION.

  Patient problems: Sepsis

  MAUDE report 20333265 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO INSTABILITY. POLY CHANGED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17406301 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAINFUL LEFT KNEE. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 15937176 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 15840104 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WENT TO SKILLED NURSING FACILITY AFTER PRIMARY AND DID NOT DO REHAB EXERCISES. TRIED MANIPULATION. OPENED AND MOVED TO 8X5 MM INSERT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Contracture

  MAUDE report 15537167 ↗
• InjuryAug 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION, IRRIGATION AND DEBRIDEMENT WITH POLY SWAP WAS DONE. THERE WAS NO DELAY IN THE SURGERY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15275747 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL LEFT KNEE. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 15265893 ↗
• InjuryMay 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LIMITED ROM IN KNEE. SURGEON EXPLANTED POLY REVISING WITH SMALLER INSERT. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 14406797 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS REMOVAL OF IMPLANTS FOR INFECTION AND IMPLANTED A SPACER. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14101515 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS UNSTABLE KNEE. UPSIZED INSERT. DOI: (B)(6) 2019, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12697130 ↗
• InjuryAug 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS CHRONIC PAIN AND DISCOMFORT. SEVERAL TEST FOR INFECTION THROUGHOUT THE YEAR AND ALL NEGATIVE. THE SURGEON REVISED THE KNEE. REMOVED ALL COMPONENTS EXCEPT PATELLA AND REVISED THE KNEE. NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Discomfort; Pain

  MAUDE report 12318453 ↗
• InjuryAug 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LEFT TOTAL KNEE THAT IS PAINFUL WITH LIMITED MOTION. ALL COMPONENTS ARE WELL FIXED, SO THE SURGEON IMPLANTED A THINNER TIBIAL INSERT. DOI: (B)(6) 2019, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 12275409 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN I&D AND A POLY SWAP WERE PERFORMED TO TREAT WOUND DRAINAGE AND ERYTHEMA. THERE WAS NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2021. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Erythema; Fluid Discharge

  MAUDE report 11938358 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017 THE PATIENT HAD A RIGHT TOTAL KNEE REPLACEMENT TO ADDRESS RIGHT KNEE OSTEOARTHRITIS WITH VARUS DEFORMITY. THERE WERE NO COMPLICATIONS NOTED DURING THE PROCEDURE. PART/LOT PAGE 4 OF 25 ON (B)(6) 2021, THE PATIENT HAD A RIGHT REVISION TO ADDRESS FAILED KNEE ARTHROPLASTY. PRIOR TO SURGERY, THE PATIENT WAS NOTED TO HAVE DEBILITATING PAIN. IT WAS NOTED THAT THE PATIENT WAS NEGATIVE FOR INFECTION, BUT LOOSENING WORK-UP WAS POSITIVE, BUT NO MENTION OF LOOSENING WAS NOTED IN THE SURGICAL NOTES. DURING THE PROCEDURE, THE SURGEON NOTED THE TIBIAL TRAY, INSERT, AND FEMUR WERE REVISED. THERE WAS NO SPECIFIC ALLEGATION OF DEFICIENCY. DOI: (B)(6) 2017 DOR: (B)(6) 2021 (RIGHT KNEE).

  Patient problems: Pain

  MAUDE report 11837058 ↗
• InjuryMar 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A PRESSFIT ATTUNE RP PS CONSTRUCT IN SEPTEMBER. THE KNEE INITIALLY DID WELL UNTIL THE PATIENT STARTED TO EXPERIENCE GLOBAL PAIN AROUND THE KNEE. THE PATIENT WAS CONFIRMED FOR NICKEL ALLERGY. ALL IMPLANTS WERE REMOVED EXPECT FOR THE PATELLA. DOI: (B)(6) 2020; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11536868 ↗
• InjuryMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS AD (B)(6) 2021 WERE REVIEWED. ON (B)(6) 2014, THE PATIENT HAD A LEFT TOTAL KNEE REPLACEMENT TO ADDRESS DEGENERATIVE JOINT DISEASE. DEPUY COMPONENTS INCLUDING DEPUY PATELLA AND DEPUY CEMENT X2 WAS UTILIZED DURING THIS PROCEDURE. ON (B)(6) 2016, THE PATIENT HAD AN EXPLANT LEFT TOTAL KNEE TO ADDRESS PAIN AND INFECTION. THE PREOPERATIVE SUMMARY INCLUDED THAT THE TIBIA TRAY IS IN SOME VARUS AND WAS ¿OBVIOUSLY LOOSE¿, NO INTERFACE PROVIDED. THE FEMORAL COMPONENT WAS NOT LOOSE, BUT WAS REVISED. NO MENTION OF REVISING THE PATELLA. THERE WAS NO MENTION OF THE MANUFACTURER OF THE SPACERS IMPLANTED DURING THIS PROCEDURE. DOI: (B)(6) 2014 DOR: (B)(6) 2016 (LEFT KNEE).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 11447821 ↗
• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE TO TREAT END-STAGE ARTHRITIS. THE PATELLA WAS RESURFACED AND UNKNOWN CEMENT WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO ADDRESS A GROSSLY INFECTED RIGHT KNEE. THE PROCEDURE WAS A STAGE-ONE OF A TWO-STAGE PLAN TO TREAT CHRONIC OSTEOMYELITIS OF THE TIBIA, FEMUR, AND PATELLA. THERE WAS A NOTED LARGE PREPATELLAR ABSCESS INFECTIOUS COLLECTION WITH SKIN NECROSIS, WOUND MEASURING APPROXIMATELY 3 X 5 CM., AND EROSION OF BONE. THE TIBIAL TRAY AND PATELLAR COMPONENT WERE BOTH LOOSE AT THE CEMENT TO IMPLANT INTERFACE. THERE WAS ALSO SYNOVITIS AND ADHESIONS. ALL COMPONENTS WERE REMOVED. A COMPETITOR ANTIBIOTIC SPACER AND PRODUCTS WERE IMPLANTED AS PART OF THE STAGE-ONE PROCEDURE. DOI: (B)(6) 2014, DOR: (B)(6) 2018 RIGHT KNEE.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Necrosis; Synovitis; Unspecified Infection

  MAUDE report 11385513 ↗
• InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO PAIN. NO SURGICAL DELAY. DOI: UNK, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11148857 ↗
• InjuryJan 6, 2021Naturally Worn; Naturally Worn

  REVISION SURGERY DUE TO PAIN. ONCE EXPLANTED THE PRODUCT HAD SOME HOLES AND SCRATCHES.

  Patient problems: Pain

  MAUDE report 11126827 ↗
• InjuryDec 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 10943133 ↗