NA 3322-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 306 adverse event reports that list this exact device (DI 10603295168621), received between Jun 29, 2017 and Aug 24, 2026 — classified as 285 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (112 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 306 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to failed rotator cuff. Total to reverse.Affected Side: Left Shoulder.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50417764 ↗
• InjuryMay 5, 2026Loss of or Failure to Bond

  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: 30 MAR 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: PATELLAR, DESCRIPTION: ATTUNE MEDIAL ANAT PAT 35MM. CATALOG NUMBER: 3322020, LOT NUMBER: 4494872, COMPONENT TYPE: PATELLAR, DESCRIPTION: SMART SET BONE CEMENT 20G.

  Patient problems: Insufficient Information

  MAUDE report 25081280 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: 01684-09491. STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ PAIN/STIFFNESS. 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 25045252 ↗
• MalfunctionApr 27, 2026Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT UPON OPENING THE BONE CEMENT BOX, IT WAS DISCOVERED THAT THE LIQUID PACKAGE WAS NOT SEALED PROPERLY RENDERING IT UNSTERILE AND UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002484 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. ANTIBIOTIC SPACER WAS PLACED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24530387 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FAILED ROTATOR CUFF, RESULTING IN THE IMPLANTATION OF A REVERSE SHOULDER SYSTEM. DOI: (B)(6) 2015. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24210837 ↗
• MalfunctionJan 16, 2026Device Damaged Prior to Receipt by User

  IT WAS REPORTED THE DEVICES WERE RECEIVED DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24098688 ↗
• MalfunctionJan 16, 2026Device Damaged Prior to Receipt by User

  IT WAS REPORTED THE DEVICES WERE RECEIVED DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24098525 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH STAGE 1 OF 2 REVISION. ANTIBIOTIC SPACER. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23879157 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE. ALL IMPLANTS WERE REMOVED AND ANTIBIOTIC SPACER WAS PLACED. THERE WERE NO DELAYS OR PATIENT INJURY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23560221 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO FAILED ROTATOR CUFF. WE TOOK OFF THE HEAD AND TAPER ADAPTER AND GLENOID. LEFT THE STEM. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23476961 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR CHRONIC RIGHT MEDIAL POSTERIOR KNEE PAIN. DEVICE RELATED: REMOTE POSSIBILITY. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: 7 JAN 2025. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION, PHYSICAL THERAPY.

  Patient problems: Pain

  MAUDE report 23404922 ↗
• MalfunctionSep 10, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Use; Device Damaged Prior to Receipt by User; Device Damaged Prior to Use

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2025. DURING THE PROCEDURE, TWO FAST SET BONE CEMENT VIALS FROM THE SAME LOT EXPLODED INTO FRAGMENTS WITH SHARP EDGES WHEN OPENED. ALL FRAGMENTS WERE REMOVED. A NEW CEMENT WAS OPENED AWAY FROM THE PATIENT AND OTHER INSTRUMENTATION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF FIVE MINUTES. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23019378 ↗
• MalfunctionSep 10, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Use; Device Damaged Prior to Receipt by User; Device Damaged Prior to Use

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2025. DURING THE PROCEDURE, TWO FAST SET BONE CEMENT VIALS FROM THE SAME LOT EXPLODED INTO FRAGMENTS WITH SHARP EDGES WHEN OPENED. ALL FRAGMENTS WERE REMOVED. A NEW CEMENT WAS OPENED AWAY FROM THE PATIENT AND OTHER INSTRUMENTATION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF FIVE MINUTES. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23019087 ↗
• InjurySep 5, 2025Loss of or Failure to Bond; No Apparent Adverse Event; Loss of or Failure to Bond; No Apparent Adverse Event

  SUBJECT ID: (B)(4). STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR KNEE REVISION DUE TO ASEPTIC LOOSENING. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: NO INFORMATION PROVIDED. DATE OF IMPLANT: ON (B)(6) 2025. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: NO INFORMATION PROVIDED. TREATMENT/IMPACT: COMPONENTS REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 22976031 ↗
• InjuryMay 12, 2025Adverse 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 INFECTED HIP. THE HEAD AND LINER WAS EXCHANGED. ALSO, THE SECOND HEAD AND LINER WAS EXCHANGED. THERE WAS NO FURTHER INFORMATION TO REPORT. DOI: (B)(6) 2025 DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22006480 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISES DUE TO THE FAILURE OF THE ROTATOR CUFF. DOI: ON (B)(6) 2021. DOR: ON (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21855482 ↗
• InjuryApr 3, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT HAD AN RIGHT TOTAL KNEE ARTHROPLASTY. DEPUY COMPONENTS INCLUDING DEPUY CEMENT AND IMPLANTS WERE UTILIZED DURING THIS PROCEDURE. ON (B)(6) 2024, THE PATIENT HAD A REVISION OF RIGHT TOTAL KNEE TO ADDRESS PAIN, SWELLING, DISCOMFORT, INSTABILITY AND DIFFICULTY AMBULATING. LIMITED RANGE OF MOTION WAS ALSO ALLEGED. OPERATIVE FINDINGS WERE NOTED THAT THE TIBIAL TRAY WAS GROSSLY LOOSE AT TIBIAL TRAY/CEMENT. DOI: (B)(6) 2015. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 21762187 ↗
• MalfunctionMar 24, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHILE OPENING A BOX OF CEMENT, A HAIR WAS NOTICED INSIDE THE PACKAGING OF THE MONOMER. A NEW PACKAGE WAS USED AND THERE WAS NO DELAY OF CASE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21675774 ↗
• InjuryJan 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT HAD A RIGHT KNEE REVISION DUE TO TIBIAL LOOSENING. PATIENT ORIGINAL SURGERY WAS (B)(6) 16, PATIENT HAD A FALL AND WHEN HE SAW SURGEON THEY TOOK AN X-RAY AND SCHEDULED FOR RIGHT KNEE REVISION DUE TO TIBIAL IMPLANT LOOSENING. THE LOOSENING WAS AT THE BONE TO CEMENT INTERFACE. THE CEMENT MANUFACTURER WAS DEPUY. DOI: (B)(6) 2016. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall

  MAUDE report 21208741 ↗
• InjuryJan 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT HAD A RIGHT KNEE REVISION DUE TO TIBIAL LOOSENING. PATIENT ORIGINAL SURGERY WAS (B)(6) 2016, PATIENT HAD A FALL AND WHEN HE SAW SURGEON THEY TOOK AN X-RAY AND SCHEDULED FOR RIGHT KNEE REVISION DUE TO TIBIAL IMPLANT LOOSENING. THE LOOSENING WAS AT THE BONE TO CEMENT INTERFACE. THE CEMENT MANUFACTURER WAS DEPUY. DOI: (B)(6) 2016. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall

  MAUDE report 21208702 ↗
• InjuryJan 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT HAD A RIGHT KNEE REVISION DUE TO TIBIAL LOOSENING. PATIENT ORIGINAL SURGERY WAS (B)(6) 2016, PATIENT HAD A FALL AND WHEN HE SAW SURGEON THEY TOOK AN X-RAY AND SCHEDULED FOR RIGHT KNEE REVISION DUE TO TIBIAL IMPLANT LOOSENING. THE LOOSENING WAS AT THE BONE TO CEMENT INTERFACE. THE CEMENT MANUFACTURER WAS DEPUY. DOI: (B)(6) 2016. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall

  MAUDE report 21208639 ↗
• InjuryJan 16, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT HAD A RIGHT KNEE REVISION DUE TO TIBIAL LOOSENING. PATIENT ORIGINAL SURGERY WAS (B)(6) 2016, PATIENT HAD A FALL AND WHEN HE SAW SURGEON THEY TOOK AN X-RAY AND SCHEDULED FOR RIGHT KNEE REVISION DUE TO TIBIAL IMPLANT LOOSENING. THE LOOSENING WAS AT THE BONE TO CEMENT INTERFACE. THE CEMENT MANUFACTURER WAS DEPUY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2016. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall

  MAUDE report 21170531 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT STARTED HAVING TROUBLE WITH ELEVATION, WEAKNESS AND PAIN. NO SPECIFIC INJURY. IMPLANTS WERE IN GOOD CONDITION WITH NO ISSUES. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Fatigue; Loss of Range of Motion; Pain

  MAUDE report 21027956 ↗
• InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS: CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION-DEEP / POSSIBLE INFECTION SEEDED FROM SINUS INFECTION. DEVICE RELATEDNESS: POSSIBLY. PROCEDURE RELATEDNESS: DEFINITELY NOT. DATE OF EVENT: 22/NOV/2024. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: NO INFORMATION PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 20894975 ↗