ATTUNE 1504-00-103Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295041047), received between Feb 4, 2020 and Apr 16, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT TKA FOR KNEE OA. WHEN A CIRCULATING NURSE OPENED THE LEFT TKA IMPLANT IN QUESTION, HE/SHE FOUND A RED FOREIGN OBJECT, APPROXIMATELY 1 MM IN SIZE, INSIDE THE STERILE PACKAGE. THE SURGEON DECIDED TO USE A NEW NARROW-SIZED PRODUCT OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 10-MINUTE DELAY. THE HOSPITAL HAS REQUESTED AN INVESTIGATION INTO THE CAUSE OF THE FOREIGN OBJECT CONTAMINATION AND A REPORT ON IT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896896 ↗
• InjuryAug 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT NOT MUCH INFORMATION AVAILABLE YET, BUT IT WAS NOTED THAT THE PATIENT HAD A DISLOCATION THE DAY AFTER SURGERY. THE IMPLANT COMPONENTS HAVE NOT SHIFTED AT ALL (I.E. FEMUR, TIBIA AND PATELLA ARE STILL PROPERLY CEMENTED IN PLACE AND THE INSERT IS STILL FULLY SEATED ON THE TIBIAL COMPONENT AS IT SHOULD BE), BUT THAT THE PATIENT¿S FEMUR HAD MOVED ANTERIORLY COMPARED TO THE TIBIA SO THAT THE FEMUR AND TIBIA WERE NO LONGER ALIGNED. FROM DISCUSSION WITH ONE OF THE SURGEONS, THE CAUSE IS NOT YET KNOWN AND FURTHER INVESTIGATIONS ARE ONGOING.

  Patient problems: Joint Dislocation

  MAUDE report 22771595 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED DUE TO INFECTION. DURING THE FIRST STAGE OF WHAT WILL BE A TWO STAGE REVISION PROCEDURE, THE PATIENT'S PRIMARY ATTUNE COMPONENTS WERE REMOVED AND REPLACED BY AN ANTIOBIOTIC SPACER. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22063817 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21938202 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENTS RECEIVED FOR IT BAND TENDINITIS. DEVICE AND PROCEDURE(RELATEDNESS), DEVICE RELATED: DEFINITELY NOT, PROCEDURE RELATED: POSSIBLY, DATE OF EVENT: 26/NOV/2024, DATE OF IMPLANT: NO INFORMATION PROVIDED, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: IRRIGATION & DEBRIDEMENT. DEPUY SYNTHES PRODUCT USED: CATALOG ID: 151820032, LOT ID: 3802592, COMPONENT TYPE: PATELLAR, DESCRIPTION: ATTUNE MEDIAL DOME PAT 32MM. CATALOG ID: 151820308, LOT ID: JP9042, COMPONENT TYPE: INSERT, DESCRIPTION: ATTUNE LEFT MEDIAL STABILIZED INSERT SIZE 3 8MM. CATALOG ID: 150400103, LOT ID: 8093073, COMPONENT TYPE: FEMORAL, DESCRIPTION: ATTUNE C/RET FEM LT SZ 3 CEMENTED. CATALOG ID: 150670003, LOT ID: 9854210, COMPONENT TYPE: TIBIAL, DESCRIPTION: ATTUNE FB CEMENTED TIBIAL BASE SIZE 3. CATALOG ID: 249095000, LOT ID: M0476R, COMPONENT TYPE: PIN, DESCRIPTION: AMK FIXATION PINS 1/8 DIA X 3. CATALOG ID: 950502303, LOT ID: M1312Z, COMPONENT TYPE: ACC, DESCRIPTION: SIGMA LCS HIGH PERFORMANCE, STERILE THREADED HEADED PINS. CATALOG ID: 3312040, LOT ID: 3807417, COMPONENT TYPE: CEMENT, DESCRIPTION: SMART SET CMW 1 40G.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 20903602 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT INITIATED COMPLAINT: IT WAS REPORTED BY OUR PATIENT THAT "ATTUNE KNEES GERMANY ORIGINAL SURGERY (B)(6) 2014 BILATERAL. REVISION SURGERY IN (B)(6) DR. LEFT SIDE IN 2019 APPROXIMATELY (B)(6) (WAS NOT SUCCESSFUL). REVISION ON LEFT (B)(6) 2020 IN (B)(6). REVISION SURGERY IN RIGHT IN (B)(6) 2021, (B)(6)."

  Patient problems: Joint Laxity

  MAUDE report 16564105 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS TO CAPTURE THE 1 X REVISION MENTIONED IN INSTRUMENT COMPLAINT (B)(4) CONFIRMED AS REVISION OF DEPUY PRODUCTS VIA RESPONSE TO "REQUEST FOR ADDITIONAL INFORMATION". INITIAL OPERATION 2018: IN THE PATIENTS NOTES FROM THE ORIGINAL OPERATION THE SURGEON COMMENTED THAT AFTER THE CUTS THE KNEE REMAINED WITH ¿GROSS TIGHTNESS¿ ON THE LATERAL SIDE. HE DOWN SIZED THE FEMUR FORM A SIZE 4 TO A SIZE 3 AND INTERNALLY ROTATED THE FEMORAL CUTS SLIGHTLY TO EASE THE TIGHTNESS. THIS WORKED TO SOME EXTENT BUT TIGHTNESS DID REMAIN. THE SURGEON DID NOT FEEL THAT THE RESIDUAL TIGHTNESS WARRANTED SOFT-TISSUE RELEASE. ACCORDING TO THE REVISION SURGEON THE PATIENT HAD EXPERIENCED POST OP PAIN AND TIGHTNESS FOR QUITE SOME TIME. THIS WAS NOT RESOLVED THROUGH PHYSIO AND EXERCISE. SO THE DECISION WAS MADE TO REVISE THE KNEE WITH THE AIM OF REDUCING PAIN AND TIGHTNESS NO BATCH NUMBERS WERE OBTAINED FROM THE EXPLANTED PROSTHESIS. THIS WAS NOT POSSIBLE DUE TO CEMENT AND TISSUE DEBRIS. (THE SECOND REVISION CASE MENTIONED IN (B)(4) DID NOT INVOLVE DEPUY SYNTHES IMPLANTS).

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 13938481 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS HYPER EXTENSION AND INSTABILITY. GOING IN WITH A HINGE. NO DELAY IN SURGERY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12512347 ↗
• InjuryJan 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT DISLOCATED DUE TO GROSS INSTABILITY. REVISED FEMUR.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 11243986 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND INSERT ROTATED 90 DEGREES. THERE WAS NO FALL NOR TRAUMA RELATED TO THE EVENT. IT WAS DETERMINED THAT THE LATERAL COLLATERAL LIGAMENT HAD PULL AWAY FROM THE FEMUR CREATING INSTABILITY. THE FEMORAL COMPONENT WAS REMOVED AND REPLACED WITH A POSTERIOR STABILIZED FEMORAL COMPONENT AND INSERT. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2020; DOR: (B)(6) 2020; LEFT KNEE.

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

  MAUDE report 10890757 ↗
• InjuryFeb 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016: PATIENT UNDERWENT A LEFT KNEE REPLACEMENT DUE TO OSTEOARTHRITIS. ATTUNE PRIMARY IMPLANTS WERE IMPLANTED WITH DEPUY CEMENT. NO INTRA-OPERATIVE COMPLICATIONS NOTED. PATIENT PRESENTED WITH PAIN, SWELLING, AND INSTABILITY. RADIOGRAPHS REVEALED FAILURE OF THE TIBIAL COMPONENT WITH SIGNIFICANT LOOSENING, LOSS OF ALIGNMENT, AND BONE LOSS. REVISION SURGERY WAS RECOMMENDED, BUT THE PATIENT REQUIRED SIGNIFICANT OPTIMIZATION TO MINIMIZE HER RISK PROFILE. SHE ALSO EXPERIENCED A GI BLEED WHICH REQUIRED BLOOD TRANSFUSION AND FURTHER TREATMENT. SHE ULTIMATELY FRACTURED HER MEDIAL TIBIAL CONDYLE WARRANTING AN URGENT REVISION SURGERY. IT SHOULD BE NOTED THE PATIENT WAS DIAGNOSED WITH A UTI PRIOR TO THE OPERATION AND WAS PROVIDED TREATMENT TO MINIMIZE HER INFECTION RISK. ON (B)(6) 2019: PATIENT UNDERWENT A LEFT KNEE REVISION. FINDINGS DURING THE SURGERY WERE WELL FIXED FEMORAL COMPONENT, GROSSLY LOOSE TIBIAL COMPONENT-CEMENT TO IMPLANT INTERFACE, TIBIAL DEFECT WITH A MEDIAL AND LATERAL CONDYLE FRACTURE-PLATE AND SCREWS PLACED, AND WELL-FIXED PATELLA COMPONENT (RETAINED). DOI: (B)(6) 2016; DOR: (B)(6) 2019; (LEFT KNEE).

  Patient problems: Edema; No Code Available; Pain; Unspecified Infection

  MAUDE report 9665088 ↗