ATTUNE 1520-20-708Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295542674), received between Mar 9, 2023 and Aug 12, 2026 — classified as 1 death, 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had reoccurring patella dislocation. There was a poly swap and quad tendon repair. No allegation against implants.DOI: (b)(6), 2026.DOR: (b)(6) 2026.Affected side: Right knee.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50226177 ↗
• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE QUAD TENDON TEAR REPAIR AND POLY SWAP; NO ALLEGATION AGAINST IMPLANT. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25599159 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24788977 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE KNEE WAS BALANCED VERY POORLY. DOI- UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24766159 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED AS THE PATIENTS KNEE WAS HYPER EXTENDING. POLY INSERT NEEDED TO BE SWAPPED. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24454439 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL WHILE DANCING, LANDING ON RIGHT KNEE AND DAMAGING QUADRICEPS TENDON. LINER WAS EXCHANGED AT SAME TIME QUAD TENDON WAS ADDRESSED. THERE WAS NO LOOSENING OF IMPLANTS, NO SUGGESTIONS OR INDICATIONS OF PROBLEM WITH ANY OF THE IMPLANTS. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Muscle/Tendon Damage

  MAUDE report 24189777 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNEE PAIN AND FLEXION CONTRACTURE. FEMUR WAS REMOVED; ALIGNMENT AND ROTATION WERE CHANGED. PATELLA IMPLANT WAS IMPLANTED TO A PREVIOUSLY NATIVE PATELLA. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Septic loosening

  MAUDE report 24183749 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH POLY EXCHANGE FOR I&D. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22751350 ↗
• InjuryAug 7, 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 LOOSENED KNEE LIGAMENTS POST SURGERY AND BECOMING UNSTABLE. RIGHT 7, 8MM MS POLY WAS REMOVED. SEQUENTIAL TRIALING WAS PERFORMED STARTING AT 10MM. THE 14MM POLY WAS DETERMINED TO PROVIDE THE LIGAMENT TENSION AND STABILITY DESIRED. IMPLANT WAS OPENED AND IMPLANTED BY SURGEON. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22737883 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED BECAUSE THE ORIGINAL KNEE WAS INFECTED. SURGEON IRRIGATED AND REPLACED THE POLY. THERE WAS NO TIME LOSS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21686375 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THEY EXPLANTED THE INFECTED KNEE, WITH THE PLACEMENT OF ANTIBIOTIC SPACER. THERE WERE NO ADVERSE CONSEQUENCES OR DELAYS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21527833 ↗
• 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 20895120 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED KNEE. WASHOUT/I&D WITH POLY SWAP OF SAME SIZE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20578142 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR A STITCH REACTION. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: REMOTE POSSIBILITY. DATE OF EVENT: (B)(6) 2024. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: THE PATIENT WAS SEEN FOR FOLLOW-UP, POST KNEE ARTHROPLASTY BY THREE WEEKS. THE PATIENT HAS A LOCALIZED SUTURE REACTION. THERE HAS BEEN PUS DRAINING OUT OF THE AREA. THE AREA WAS CLEANED AND DEBRIDED AND PLACED ON ORAL ANTIBIOTICS. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 151820041, LOT NUMBER: 4534213, COMPONENT TYPE: PATELLAR, DESCRIPTION: ATTUNE MEDIAL DOME PAT 41MM. CATALOG NUMBER: 150401207, LOT NUMBER: 4513837, COMPONENT TYPE: FEMORAL, DESCRIPTION: ATTUNE CR FEM RT SZ 7 POR. CATALOG NUMBER: 152020708, LOT NUMBER: M5164N, COMPONENT TYPE: INSERT, DESCRIPTION: ATTUNE RIGHT MEDIAL STABILIZED INSERT SIZE 7 8MM. CATALOG NUMBER: 150621007, LOT NUMBER: 4461808, COMPONENT TYPE: TIBIAL, DESCRIPTION: ATTUNE FB TIB BASE SZ 7 POR. CATALOG NUMBER: 3322020, LOT NUMBER: 4389262, COMPONENT TYPE: CEMENT, DESCRIPTION: SMART SET BONE CEMENT 20G.

  Patient problems: Fluid Discharge; Hypersensitivity/Allergic reaction; Unspecified Infection

  MAUDE report 20532378 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: ON (B)(6) 2024, THE PATIENT HAD A VISIT WITH THE PHYSICIAN ASSISTANT 5 MONTHS OUT FROM RECEIVING BILATERAL KNEE REPLACEMENTS. THE PATIENT¿S RIGHT KNEE IS NOW PAINFUL AND DOESN¿T FEEL LIKE IT IS IMPROVING. A LOT OF SYNOVITIS, THICKENED SYNOVIUM AND FLUID IN THE KNEE WAS IDENTIFIED. ON (B)(6) 2024, THE PATIENT RETURNS TO THE SURGEON. ON XRAY THERE IS RESORPTION IN TIBIA ZONE 1 AND THE POSTERIOR FLANGE OF THE FEMUR. THE SURGEON SUSPECTS A CHRONIC LOW-GRADE INFECTION. HE PLANS TO EITHER PERFORM A 1-STAGE REVISION OR EXPLANT WITH A TEMPORARY ANTIBIOTIC SPACER DEPENDENT ON WHAT THE CULTURES GROW WITHIN THE NEXT COUPLE WEEKS.

  Patient problems: Extraskeletal ossification; Fluid Discharge; Pain; Synovitis; Unspecified Infection

  MAUDE report 20422394 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD AN I&D WASHOUT. THE POLY WAS CHANGED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE. ADDITIONAL EVENT INFORMATION: WASHOUT WAS DUE TO POSSIBLE INFECTION. LOOKED TO BE SUPERFICIAL BUT CHANGED INSERT TO BE ON THE SAFER CLEANER SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 20156650 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH POLY EXCHANGE DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19948870 ↗
• MalfunctionJun 5, 2024Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PACKING HAD A PUNCTURE AND IS NO LONGER STERILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19469451 ↗
• InjuryApr 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2024 THE NON-INFECTED PATIENT FELL, RESULTING IN POLY LOOSENING. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall

  MAUDE report 19079489 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY WAS EXCHANGE AND WASHED OUT, DUE TO A SUSPECTED INFECTION. DOI: (B)(4) 2024. DOR: (B)(4) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18838571 ↗
• DeathFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). ASSOCIATED STUDY: REGISTRY, DATE OF EVALUATION: (B)(6) 2024, DATE OF ONSET: 25/JAN/2024, DIAGNOSIS: DEATH, COUNTRY: US, SERIOUS: YES, DEVICE RELATED: DEFINITELY NOT, PROCEDURE RELATED: REMOTE POSSIBILITY, SUBJECT'S AGE AT ENROLLMENT: 78, SUBJECT'S GENDER: MALE, SUBJECT'S HEIGHT: 70 IN, SUBJECT'S WEIGHT: 142 LBS. (B)(4) ARE RELATED TO EACH OTHER. BOTH COMPLAINTS ARE CREATED FOR THE BILATERAL KNEES. (B)(4) CAPTURE THE LEFT KNEE. (B)(4) CAPTURE THE RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18749588 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR GI BLEED. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023, DATE OF EVENT: (B)(6) 2023, (RIGHT KNEE). TREATMENT: BLOOD GIVEN; PANTOPRAZOLE DEPUY PRODUCTS USED (NO REVISION COMPLETED) :

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16815096 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION AND LOOSENING OF THE FEMUR AND TIBIA AT THE BONE TO IMPLANT INTERFACE. PATIENT HAS A PERI PROSTHETIC JOINT INFECTION AND A STAGE 1 ANTIBIOTIC SPACER WAS IMPLANTED. DOI: (B)(6) 2022 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16512341 ↗