ATTUNE 1516-40-306Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295049654), received between Mar 28, 2018 and Apr 8, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 other recall cover devices cleared under the same FDA submission (K111433, K233980); 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE PATIENT REVISED DUE TO SURGEON SUSPICION OF INSTABILITY. AFFECTED SIDE: LEFT.

  Patient problems: Joint Laxity

  MAUDE report 24815728 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORT: THE PATIENT WAS REVISED DUE TO PAIN. THE PHYSICIAN REVISED FEMUR COMPONENTS TO CRS WITH STEM. DOI: (B)(6) 2017, DOR: (B)(6) 2021: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12487175 ↗
• InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2016 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT WAS UTILIZED X2. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2019 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. UPON ENTERING THE JOINT, SCAR TISSUE WAS ENCOUNTERED AND REMOVED. ALL IMPLANTS WITH THE EXCEPTION OF THE PATELLA WERE REVISED. THE SURGERY WAS COMPLETED. DOI: (B)(6) 2016, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 11148274 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS A STIFF KNEE.

  Patient problems: Adhesion(s); Edema; No Code Available; Pain

  MAUDE report 10392197 ↗
• InjuryMay 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL KNEE. DOI: (B)(6) 2017. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10102596 ↗
• InjuryDec 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN AND INSTABILITY. THE SURGEON NOTED REMOVAL OF ADHESIONS AND HETEROTOPIC BONE AROUND THE PATELLA. THE PATELLA COMPONENT WAS NOT REVISED. THE SURGEON ALSO NOTED SCLEROTIC SURFACES. COMPETITOR CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2016; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Adhesion(s); No Code Available; Pain

  MAUDE report 9475320 ↗
• InjuryNov 15, 2019Naturally Worn; Naturally Worn

  THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN, ARTHROFIBROSIS, ADHESIONS, DECREASED RANGE OF MOTION, STIFFNESS, AND TIBIAL INSERT WEAR CAUSED BY ECTOPIC CEMENT FROM THE FEMUR. THE SURGEON NOTED ONE LARGE PIECE OF CEMENT AND SEVERAL SMALLER PIECES THAT WERE REMOVED. ONE FRAGMENT OF CEMENT LOCATED AT THE TIP OF THE MEDIAL CONDYLE WAS NOT ACCESSIBLE THROUGH THE WOUND AND DID NOT APPEAR TO BE SOMETHING WHICH COULD CAUSE SYMPTOMS, ACCORDING TO THE SURGEON, AND WAS LEFT IN PLACE. THE TIBIAL INSERT AND LOOSE CEMENT PARTICLES WERE THE ONLY PRODUCTS REVISED. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2014; DOR: (B)(6) 2016; LEFT KNEE.

  Patient problems: Adhesion(s); No Code Available; Pain

  MAUDE report 9332348 ↗
• InjuryNov 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PARTIAL MOTOR WEAKNESS OF RIGHT ANKLE DORSIFLEXORS ASSOCIATED WITH CORRECTION OF VALGUS DEFORMITY AND A PRESUMED COMMON PERONEAL NERVE PALSY. EVENT IS NOT RELATED TO DEVICE AND IS RELATED TO PROCEDURE. EVENT IS CONSIDERED ONGOING; PHYSICAL THERAPY ORDERED.

  Patient problems: Neurological Deficit/Dysfunction; No Code Available; Weakness

  MAUDE report 8029155 ↗
• InjuryMar 28, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDICAL RECORDS RECEIVED 1-MAR-2018. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT WAS IMPLANTED ON (B)(6) 2015 WITH A RIGHT KNEE. SHE SUSTAINED A POSTERIOR DISLOCATION IN (B)(6) 2017 AND HAD A CLOSED REDUCTION. SHE HAD AN ADDITIONAL POSTERIOR DISLOCATION AND THEN UNDERWENT A REVISION OF THE TIBIAL INSERT ON (B)(6) 2017. INSTABILITY WAS ALSO NOTED. DOI: (B)(6) 2015 DOR: (B)(6) 2017 (RIGHT KNEE).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 7377304 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111433, K233980. One submission often covers many models, so check the product and lot details in each record.

• Z-1267-2023 · Feb 15, 2023 · Open, Classified
  Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507