NA 86-7432Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295217923), received between Nov 14, 2018 and Jan 7, 2026 — classified as 20 injuries.

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

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF FEMUR AT CEMENT TO IMPLANT INTERFACE AND STABILITY. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A PREVIOUS TRAUMATIC INJURY. THE PREVIOUS IMPLANTS WERE UPSIZED BECAUSE OF LOOSENING IN THE TIBIA AND FEMUR AND THE ACTUAL POLYETHYLENE WAS NOT WORN OUT. DOI: (B)(6) 2018. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23992686 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED DUE TO INFECTION. ALL PARTS WERE EXPLANTED AND A CEMENT SPACER FROM A DIFFERENT VENDOR WAS IMPLANTED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23016528 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: THE SIGMA FEMORAL COMPONENT, FEMORAL SLEEVE, FEMORAL STEM, INSERT, TIBIAL TRAY, TIBIAL SLEEVE, AND TIBIAL STEM WERE REVISED FOR INFECTION. THE INSERT SHOWED MODERATE YELLOWING.

  Patient problems: Unspecified Infection

  MAUDE report 22686240 ↗
• InjuryApr 28, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE SURGEON REVISED LCS FEMORAL COMPONENTS DUE TO COMPONENT LOOSENING. THE SURGEON WAS MADE AWARE THAT ATTUNE REVISION COMPONENTS ARE NOT APPROVED FOR ON LABEL USE WITH AN MBT REVISION TRAY. THE SURGEON FELT IT WAS IN THE BEST INTEREST OF THE PATIENT TO MOVE FORWARD WITH USING ATTUNE REVISION IMPLANTS IN AN OFF-LABEL USE WITH THE EXISTING MBT REVISION TRAY. THERE WAS FEMUR AND PRESSFIT STEM LOOSENING. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6), 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21917960 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE ER IN (B)(6) 2025 WITH BILATERAL INFECTED KNEES FROM AN ACUTE INFECTION IN THE PATIENTS BLOOD. IT AFFECTED BOTH THE KNEES WHICH HAD REV IMPLANTS IN AND BOTH THE SHOULDERS WHICH HAD NO IMPLANTS. PATIENT WAS WASHED OUT AND IMPLANT EXCHANGES TOOK PLACE ON 2 SEPARATE OCCASIONS AT A DIFFERENT FACILITY. PATIENT CAME INTO CLINIC FOR FOLLOW UP ON (B)(6) 2025 AND BOTH KNEES APPEARED TO STILL BE INFECTED. CULTURES SHOWED A SENSITIVE STREP. SURGEON ADMITTED THE PATIENT AND BILATERAL KNEE REVISIONS WERE PERFORMED IN A ONE STAGE FASHION TO INCLUDE THOROUGH IRRIGATION AND DEBRIDEMENT AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. THERE WAS NO DELAY NOR PATIENT HARM NOTED. NO ALLEGATIONS WERE MADE AGAINST ANY COMPONENT AS THIS WAS FROM AN ORGANISM IN PATIENT BLOOD THAT AFFECTED MULTIPLE JOINTS IN PATIENT'S BODY. DATE OF IMPLANTATIONS: RIGHT REVISION KNEE WAS (B)(6) 2016. NO INFORMATION WAS AVAILABLE WITH REGARD TO PRODUCTS EXPLANTED ON (B)(6) 2016. LEFT REVISION KNEE WAS (B)(6) 2023. NO INFORMATION AVAILABLE WITH REGARD TO PRODUCTS EXPLANTED ON (B)(6) 2023. ON (B)(6) 2025, AN I&D AND INSERT EXCHANGE TOOK PLACE FOR THE LEFT KNEE FOR HEMATOMAS, AND P

  Patient problems: Unspecified Infection

  MAUDE report 21883407 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT FEMUR WAS REVISED DUE TO THIGH PAIN. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21294684 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED TO HAVE CONTINUED PAIN IN EVERYDAY ACTIVITIES. THE PATIENT UNDERWENT REVISION SURGERY.

  Patient problems: Pain

  MAUDE report 20557120 ↗
• InjuryOct 14, 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 CHRONIC INFECTION OF RIGHT KNEE. DOI: (B)(6) 2020 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20440004 ↗
• InjuryJan 19, 2024Fracture; Noise, Audible; Migration; Fracture; Noise, Audible; Migration

  ADDITIONAL INFORMATION WAS RECEIVED. 1. WAS THIS A RIGHT KNEE CUSTOM LPS CONSTRUCT? YES. 2. WERE THERE TWO SEGMENTAL COMPONENTS UTILIZED WITH THE DISTAL FEMORAL CONSTRUCT? NO. 3. WAS THERE ANY INDICATION, THAT THE FEMORAL SLEEVE FRACTURED? ANY ADDITIONAL INFORMATION THAT CAN BE PROVIDED TO CONFIRM, THE CORRECT PRODUCT CODES WOULD BE APPRECIATED. THE PATIENT, HEARD A CRACK. AND AFTER THAT, THE PATIENT HAD PAIN.

  Patient problems: Pain; Physical Asymmetry

  MAUDE report 18543927 ↗
• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PATIENT COMPLAINTS OF PAIN AND INSTABILITY. IN SURGERY SURGEON FOUND FEMUR TO BE LOOSE, BUT TIBIA SOLID. A HINGED FEMUR ALONG WITH SLEEVE AND STEM AND THICKER POLY WAS IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2022. RIGHT FEMUR.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13446146 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS HAD MULTIPLE OPERATIONS. IMPLANT DATES RELATING TO THIS SURGERY ARE AS FOLLOWS: STEM, SLEEVE AND CABLE ON (B)(6) 2018. DISTAL FEMUR AND INSERT ON (B)(6) 2020. THIS COMPLAINT CAPTURES THE PATELLA TENDON RUPTURE REPAIR (B)(6) 2020. PATIENT HAD A PATELLA TENDON RUPTURE AFTER HER SURGERY ON (B)(6) 2020 WHICH WAS REPAIRED ON THE (B)(6) 2020 SURGERY. DOI (B)(6) 2021 ADAPTER. DOR: (B)(6) 2021. RIGHT KNEE

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 12041677 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. DATE OF IMPLANTATION. NOT SURE SORRY. B. LOT NUMBER: UNIVERSAL STEM 115X14MM FLUTED (867428) AND LPS XX-SM HINGE PIN. REFER IMAGE UPLOADED. C. PLEASE CONFIRM IF THE CEMENT WAS MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE QUANTITY, PART AND LOT NUMBERS OF THE CEMENT. NO STYKER.

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

  MAUDE report 11796230 ↗
• InjuryMar 19, 2021Migration; Migration

  THE PATIENT'S KNEE WAS REVISED DUE TO THE FEMORAL SIDE SLEEVE/STEM CONSTRUCT SUBSIDING. NO DELAY IN SURGERY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11527288 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 10986313 ↗
• InjuryJul 20, 2020Fracture; Fracture

  PRESS FIT STEM IN PREVIOUS TOTAL KNEE ARTHROPLASTY BROKE AT THREADS OFF CEMENTED FEMORAL SLEEVE. PAIN REPORTED & REVISION SURGERY REQUIRED.

  Patient problems: No Code Available; Pain

  MAUDE report 10299180 ↗
• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO CHRONIC INFECTION. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9874278 ↗
• InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. ALL COMPONENTS HAD TO BE REMOVED AND STATIC CEMENT SPACER WAS IMPLANTED IN HOPES OF CURING THE INFECTION. CEMENT COVERED MOST OF ALL THE PRODUCT NUMBERS SO UNABLE TO READ COMPONENT SIZES AND LOT NUMBERS. POLY WAS DESTROYED GETTING IT OUT SO NO NUMBERS WERE VISIBLE ON IT EITHER. DOI: UNKNOWN. DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8992465 ↗
• InjuryApr 22, 2019Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AND FEMORAL SLEEVE AT BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS REVISED. DOI: (B)(6) 2013. DOR: (B)(6) 2019; RIGHT KNEE

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8536975 ↗
• InjuryJan 17, 2019Loss of Osseointegration; Loss of Osseointegration

  PATIENT HAD KNEE REVISION FOR LOOSE FEMORAL REVISION COMPONENT. METAPHYSEAL SLEEVE & PRESS FIT STEM WERE LOOSE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8256511 ↗
• InjuryNov 14, 2018Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL TRAY, SLEEVE AND STEM COMPONENT AT THE BONE TO CEMENT INTERFACE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8069731 ↗