ATTUNE 1547-05-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295382751), received between May 3, 2019 and Jan 13, 2026 — classified as 27 injuries.

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 27 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POSSIBLE INFECTION OF REVISION RTKA THAT WAS IMPLANTED (B)(6) 2024. REMOVED ALL IMPLANTS AND WASHED OUT AND PERFORMED A 1 1/2. STAGE REVISION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24054545 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 23526907 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 23526869 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTION. SURGEON REMOVED IMPLANTS AND PLACED AN ANTIBIOTIC SPACER. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22968149 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OPERATIVE X-RAYS SHOWED A FEMUR FRACTURE. SURGEON DECIDED TO REMOVE IMPLANTS AND REDUCE FRACTURE/REPOSITION KNEE REVISION. NO COMPLAINTS ABOUT INSTRUMENTATION OR IMPLANTS AND THERE WAS NO DELAY TO SURGERY TIME. THE FEMORAL BONE FRACTURED, THE IMPLANT WAS INTACT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 22034799 ↗
• InjuryJan 22, 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 PAIN. NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21209910 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED AN ATTUNE REVISION OPERATION TO REMEDY AN INFECTED PRIMARY CONSTRUCT (ZIMMER). THE ATTUNE REVISION CONSTRUCT HAS CAUSED THE PATIENT ISSUES SINCE SOON AFTER THE REVISION OPERATION. TODAY THE ATTUNE REVISION IMPLANTS WERE REMOVED DUE TO CONTINUED INFECTION ISSUES

  Patient problems: Unspecified Infection

  MAUDE report 18713557 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A DISTAL FEMORAL REPLACEMENT DUE TO PRIOR INFECTION AND SOFT TISSUES STRETCHING EXTENSIVELY RESULTING IN THE DISLOCATION OF THE HINGED COMPONENT WITH THE LARGEST AVAILABLE POLY. THE DISTAL FEMORAL COMPONENT WITH A POROUS STEM WAS LOOSE AND REMOVED EASILY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 17058411 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A DISTAL FEMORAL REPLACEMENT DUE TO PRIOR INFECTION AND SOFT TISSUES STRETCHING EXTENSIVELY RESULTING IN THE DISLOCATION OF THE HINGED COMPONENT WITH THE LARGEST AVAILABLE POLY. THE DISTAL FEMORAL COMPONENT WITH A POROUS STEM WAS LOOSE AND REMOVED EASILY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 17058138 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  PATIENT UNDERWENT REVISION FOR INSTABILITY. PATIENT'S PRIMARY WAS WITH COMPETITOR PRODUCTS ON A UNKNOWN DATE. PATIENT HAD FIRST REVISION (REASON UNKNOWN) ON (B)(6) 2022 WHERE OUR PRODUCTS WERE IMPLANTED. PATIENT HAD 2ND REVISION ON THE (B)(6) 2022 FOR INSTABILITY, (B)(4). THEN A 3RD REVISION FOR INSTABILTY, THIS PC, ON THE (B)(6) 2023.

  Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037537 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  PATIENT UNDERWENT REVISION FOR INSTABILITY. PATIENT'S PRIMARY WAS WITH COMPETITOR PRODUCTS ON A UNKNOWN DATE. PATIENT HAD FIRST REVISION (REASON UNKNOWN) ON (B)(6) 22, WHERE OUR PRODUCTS WERE IMPLANTED. PATIENT HAD 2ND REVISION ON THE (B)(6) 22, FOR INSTABILITY, (B)(4). THEN A 3RD REVISION FOR INSTABILTY, THIS PC, ON THE (B)(6) 23.

  Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037509 ↗
• InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A SECOND REVISION WAS COMPLETED DUE TO DISLOCATION. THE FEMORAL COMPONENT, SLEEVE, AND STEM WERE REMOVED AND SROM HINGE WAS IMPLANTED SECONDARY TO BONE FRACTURE. DOI: 09/1/2022, DOR: 12/21/2022, AND DOR: 02/05/2023.

  Patient problems: Bone Fracture(s); Joint Laxity

  MAUDE report 16407294 ↗
• InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A SECOND REVISION WAS COMPLETED DUE TO DISLOCATION. THE FEMORAL COMPONENT, SLEEVE, AND STEM WERE REMOVED AND SROM HINGE WAS IMPLANTED SECONDARY TO BONE FRACTURE. DOI: (B)(6) 2022. DOR: (B)(6) 2022. DOR: (B)(6) 2023.

  Patient problems: Bone Fracture(s); Joint Laxity

  MAUDE report 16407292 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT HE NEED TO SPEAK TO SOMEONE WITH THE DEPUY DIVISION. HE HAS A FEW QUESTIONS IF THERE IS A RECALL WITH THE PRODUCT. HE HAD SOME PROBLEMS WITH THE PRODUCT THAT WAS ON HIS LEFT LEG AND IT WAS SUPPOSED TO LAST 10-15 YEARS BUT IT ONLY LASTED FOR 2 YEARS(SCN). DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort; Pain

  MAUDE report 15264826 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT HE NEED TO SPEAK TO SOMEONE WITH THE DEPUY DIVISION. HE HAS A FEW QUESTIONS IF THERE IS A RECALL WITH THE PRODUCT. HE HAD SOME PROBLEMS WITH THE PRODUCT THAT WAS ON HIS LEFT LEG AND IT WAS SUPPOSED TO LAST 10-15 YEARS BUT IT ONLY LASTED FOR 2 YEARS(SCN). DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort; Pain

  MAUDE report 15264824 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE TOTAL KNEE ARTHROPLASTY WITH THE ATTUNE FOR THE OSTEOARTHRITIS OF THE RIGHT KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT WAS INFECTED. THEREFORE, ON (B)(6) 2022, ALL THE IMPLANTS WERE REMOVED. AT FIRST, THE SURGEON PLANNED TO REMOVE THE INSERT, REPLACED AND CLEANSED; HOWEVER, THE IMPLANTS WERE LOOSENED. CONSEQUENTLY, THE SURGEON REMOVED ALL THE IMPLANTS AND INSERTED CEMENT MOLD. ACCORDING TO THE SURGEON, THE PATIENT HAD DIABETES AND WAS NOT WELL CONTROLLED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2021, DOR: (B)(6) 2022, RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15113134 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE TOTAL KNEE ARTHROPLASTY WITH THE ATTUNE FOR THE OSTEOARTHRITIS OF THE RIGHT KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT WAS INFECTED. THEREFORE, ON (B)(6) 2022, ALL THE IMPLANTS WERE REMOVED. AT FIRST, THE SURGEON PLANNED TO REMOVE THE INSERT, REPLACED AND CLEANSED; HOWEVER, THE IMPLANTS WERE LOOSENED. CONSEQUENTLY, THE SURGEON REMOVED ALL THE IMPLANTS AND INSERTED CEMENT MOLD. ACCORDING TO THE SURGEON, THE PATIENT HAD DIABETES AND WAS NOT WELL CONTROLLED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2021. DOR: (B)(6) 2022. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15113105 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 14714296 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 14714269 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POLY CHANGE FROM REVISION KNEE 3 YEARS AGO. NO ISSUE WITH POLY, LIMITED FLEXSION ~85°. PRESENT IN BOTH KNEES (ONE DPS / ONE EXATECH). DOI: (B)(6) 2019.

  Patient problems: Inflammation; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 13900353 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POLY CHANGE FROM REVISION KNEE 3 YEARS AGO. NO ISSUE WITH POLY, LIMITED FLEXSION 85° PRESENT IN BOTH KNEES (ONE DPS / ONE EXATECH). DOI: (B)(6) 2019.

  Patient problems: Inflammation; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 13900351 ↗
• InjuryJun 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR TROCHANTERIC BURSITIS, HIP AND KNEE PAIN AND CREPITUS EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: INJECTED MEDICATION (UNSPECIFIED) AND PHYSICAL THERAPY.

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

  MAUDE report 12073125 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ATUNE REVISION IMPLANTS WERE REMOVED DUE TO UNKNOWN REASONS. DOI: UNKNOWN; DOR: (B)(6) 2020; UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10723061 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE ORIGINAL IMPLANTS WERE PUT IN ON (B)(6) 2018, THE POLY SWAP WAS DONE ON (B)(6) 2020, THEN THE EXPLANT WAS DONE ON (B)(6) 2020.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10723060 ↗
• InjuryDec 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD ALL IMPLANTS REMOVED DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9443941 ↗