ATTUNE 1516-50-712Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295052753), received between Jun 21, 2017 and Oct 15, 2025 — classified as 21 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS INFECTED WITH MERSA SO ALL OF HER PREVIOUS IMPLANTS WERE TAKEN OUT TO BE REPLACED WITH ANTIBIOTIC SPACERS. NO PATIENT CONSEQUENCES.

  Patient problems: Unspecified Infection

  MAUDE report 23289445 ↗
• InjuryJun 16, 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 PAINFUL KNEE. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 22211263 ↗
• InjuryJun 11, 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 INFECTED SO DOC DECIDED TO DO A WASHOUT WITH A POLY EXCHANGE. OLD POLY CAME OUT AND NEW POLY WENT IN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Unspecified Infection

  MAUDE report 22185913 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT NEEDED A THICKER POLY. NO FURTHER INFORMATION IS PROVIDED. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20866874 ↗
• InjuryMay 13, 2024Adverse 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 INFECTION. A POLY EXCHANGE WAS PERFORMED. THERE WAS NO SURGICAL DELAY EXPERIENCED. THERE WAS NO BROKEN INSTRUMENTATION. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19305214 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POLY EXCHANGE DUE TO INFECTION. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19271468 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16643316 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ANTIBIOTIC SPACER WAS IMPLANTED TO STAGE INFECTION. NO OTHER INFORMATION WAS GIVEN. THE CEMENT MANUFACTURER WAS NOT INDICATED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16252137 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: INJECTED MEDICATION (CORTISONE).

  Patient problems: Pain

  MAUDE report 15966235 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. THE CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15323767 ↗
• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. UNKNOWN IF ANY LOOSENING. UNKNOWN IF ANY SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6), 2022 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14399825 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AND REVIEWED: ON (B)(6) 2016, THE PATIENT HAD A LEFT TOTAL KNEE REPLACEMENT TO ADDRESS DEGENERATIVE JOINT DISEASE, LEFT KNEE, WITH VARUS DEFORMITY. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT X1 WERE USED DURING THIS PROCEDURE.. ON (B)(6) 2018, THE PATIENT HAD A REVISION LEFT TOTAL KNEE TO ADDRESS FAILED LEFT TOTAL KNEE REPLACEMENT. THE INDICATIONS FOR SURGERY NOTED THAT THE PATIENT HAD BEEN HAVING PERSISTENT PAIN. DURING THE PROCEDURE THE SURGEON OBSERVED MASSIVE AMOUNT OF SYNOVITIS AND THE FEMORAL COMPONENT WAS NOTED TO BE ¿QUITE LOOSE FROM THE BONE. IT SEEMED TO BE A FAILURE OF THE CEMENT BONE INTERFACE.¿ THERE WERE OSTEOLYTIC CRATERS IN BONE. THE TIBIAL TRAY HAD NO CEMENT BONDED TO IT. THERE WAS NO OBSERVABLE WEAR ON THE INSERT. DEPUY COMPONENTS WERE USED IN CONJUNCTION WITH COMPETITOR CEMENT DURING THIS PROCEDURE. DOI: (B)(6) 2016 DOR: (B)(6) 2018 (LEFT KNEE).

  Patient problems: Joint Laxity; Osteolysis; Pain; Synovitis

  MAUDE report 12019044 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO THE PRESENCE OF INFECTION. PLACEMENT OF ANTIBIOTIC SPACER WAS DONE. NO SURGICAL DELAY. DOI: UNK, DOR: (B)(6) 2020, RIGHT KNEE.

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

  MAUDE report 11142762 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10810056 ↗
• InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. POLY THICKNESS WAS INCREASED. NOTHING FURTHER TO REPORT. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10315874 ↗
• InjuryJun 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS STRETCHED LIGAMENTS. INSERT WAS REVISED. DOI: (B)(6) 2018; DOR: (B)(6) 2020; LEFT KNEE

  Patient problems: No Code Available

  MAUDE report 10112323 ↗
• InjurySep 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD (B)(6) 2019. THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, INSTABILITY, FREQUENT FALLS, DECREASED RANGE OF MOTION, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THREE DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2016, DOR: (B)(6) 2018, RIGHT KNEE.

  Patient problems: Loss of Range of Motion; No Code Available; Pain

  MAUDE report 9083764 ↗
• InjuryMar 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES PATIENT WAS IN A CAR ACCIDENT. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7370083 ↗
• InjuryMar 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD I&D WASH OUT OF HER BELIEVED INFECTED LEFT TOTAL KNEE ON (B)(6) 2017 WHERE HER INSERT WAS EXCHANGED. THIS DAY SHE PRESENTED WITH A DRAINING PAINFUL LEFT TOTAL KNEE. THE SURGEON FELT BEST TREATMENT FOR THIS WAS TO REMOVE THE COMPONENTS AND PLACEMENT OF ANTIBIOTIC SPACERS. NO LOT NUMBERS WERE AVAILABLE THEY DID NOT TRANSFER OVER WITH THE NEW SCHEDULING SYSTEM.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7330686 ↗
• InjuryFeb 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DER STATES THAT THE PATIENT UNDERWENT I AND D AND HAS POSSIBLE INFECTION. DOI: (B)(6) 2018; DOR: (B)(6) 2018 UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7283748 ↗
• InjuryJun 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS WASH OUT AND INSERT EXCHANGE DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6658413 ↗