NA 1294-53-226Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10603295026303), received between Sep 15, 2017 and Apr 14, 2026 — classified as 50 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (11 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 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY OF TC3. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24876439 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED WITH TC3 FEMUR WITH POROUS COATED SLEEVE DUE TO INSTABILITY. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23803030 ↗
• InjuryDec 1, 2025Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: 1. WHY WAS THE FEMORAL STEM REPLACED? IS THERE ANY ALLEGATION OF MALFUNCTION AGAINST THE STEM OR ANY OF THE OTHER IMPLANTS.- THE STEM IS ATTACHED TO THE SLEEVE AND IS REPLACED WHEN THE NEW IMPLANTS ARE PLACED.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 23680579 ↗
• InjuryNov 3, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAD A PREVIOUS HINGE KNEE REVISION DONE ON (B)(6) 2021. THE FEMUR BECAME LOOSE AND BROUGHT IN FOR REVISION. PREVIOUS TIBIAL COMPONENTS WERE RETAINED. A NEW HINGE FEMUR, FEMORAL CONE, CEMENTED STEM AND NEW HINGE INSERT WERE IMPLANTED. FEMUR, SLEEVE AND STEM WERE LOOSE. THERE WAS NO DELAY IN SURGERY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23453515 ↗
• InjuryAug 25, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAS A PERSISTENT INFECTION POST TKA UTILIZING REVISION COMPONENTS DUE TO EXTREME DEFORMITY. ALL COMPONENTS WERE REMOVED AND A STATIC SPACER WAS PLACED UTILIZING LPS COMPONENTS FOLLOWING A THOROUGH DEBRIDEMENT. RESORBABLE ANTIBIOTIC BEADS WERE ALSO PLACED. PATIENT HAS HAD MULTIPLE I&DS FOLLOWING THIS PROCEDURE AND DERS WERE SUBMITTED FOR EACH. POROUS COMPONENTS DID NOT SHOW INGROWTH, SUGGESTING THAT THE INFECTION HAS BEEN PRESENT THROUGHOUT CARE. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 22883561 ↗
• InjuryJun 16, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT'S DISTAL FEMORAL REPLACEMENT WAS REVISED BECAUSE THE 13X90 CEMENTED STEM BROKE OFF AT THE FEMORAL SLEEVE JUNCTION. THERE WAS LOOSENING OF FEMORAL SLEEVE AT NON CEMENTED INTERFACE DUE TO STEM BREAKING. UNKNOWN CEMENT WAS USED. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22213990 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE LOSS OF FIXATION TO THE OSTEOTOMY IS WHAT LED TO THE POOR PATELLAR TRACKING. IMPLANTS WERE PERFORMING AS EXPECTED.

  Patient problems: Joint Laxity

  MAUDE report 22021391 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POST OPERATIVE HEMATOMA AFTER A COMPLEX PRIMARY KNEE REPLACEMENT UTILIZING REVISION COMPONENTS. ALL COMPONENTS WERE REMOVED AND EXCHANGED UNEVENTFULLY WITH NO PATIENT HARM NOR DELAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hematoma

  MAUDE report 21944654 ↗
• 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 21883520 ↗
• InjuryJan 30, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR FEMORAL LOOSENING. ALL FEMORAL COMPONENTS LOOSE. THE ENTIRE FEMORAL CONSTRUCT WAS LOOSE. IT CAME OUT WITH A FEW TAPS WITH CEMENT STILL STUCK TO THE FEMORAL COMPONENTS AND NO VISIBLE INGROWTH ON THE SLEEVE. SO, IT WAS LOOSE AT BOTH THE CEMENT-BONE AND IMPLANT-BONE INTERFACES. THE CEMENT MANUFACTURER WAS UNKNOWN AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21272675 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI- (B)(6) 2019. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17480621 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION AND LOOSENING OF THE TIBIAL TRAY AT THE BONE TO CEMENT INTERFACE AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. TWO DEPUY CEMENTS WERE USED. IMPLANTS WERE REMOVED AND INSERTION OF ANTIBIOTIC SPACER WAS PERFORMED. DOI: (B)(6) 2015. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14103929 ↗
• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOI (B)(6) 2014: THE INFECTION WAS CLEARED AND AN LPS DISTAL FEMUR, SEGMENT COMPONENT, SLEEVE ADAPTOR, FEMORAL SLEEVE, LPS TIBIAL HINGE INSERT, UNIVERSAL STEM, MBT TRAY, MBT SLEEVE, AND UNIVERSAL STEM (SEE ADDITIONAL INFORMATION PROVIDED WITH PART/LOT) WAS IMPLANTED. A FREE LATISSIMUS DORSI FLAP WITH VEIN GRAFTING TO CORRECT A LEFT KNEE SKIN DEFECT PRESENT BEFORE THE REVISION WAS ALSO PERFORMED. POSTOPERATIVELY, THE DEVELOPED ACUTE RENAL FAILURE REQUIRING INCREASING IV FLUIDS. THIS WAS CAPTURED IN (B)(4). ON (B)(6) 2014: THE LATISSIMUS DORSI FLAP IS POSITIVE FOR PSEUDOMONAS AND STENOTROPHOMONAS MALTOPHILIA REQUIRING IV ANTIBIOTICS AND A WOUND VAC DRESSING TO ADDRESS THE DRAINAGE. THE INFECTION IS CLEARED THOUGH THE PATIENT IS TOLD TO REMAIN ON CHRONIC ANTIBIOTICS. THIS WAS CAPTURED IN (B)(4). ON (B)(6) 2014: THE EXTENSOR MECHANISM HAS ¿SLID PROXIMALLY¿ CAUSING BONE GRAFT TO COME LOOSE AND PATELLA TO RIDE HIGH PER RADIOGRAPHS IN REFERENCE TO HIS ALLOGRAFT RECONSTRUCTION WITH RESIDUAL ROM AND STRENGTH DEFICITS. NO SURGICAL INTERVENTION IS TO BE DONE. HE IS TO CONTINUE PHYSICAL THERAPY ONLY. THIS WAS CAPTURED IN (B)(4). EARLY (B)(6) 2014: THE PATIENT SUSTAINS A FALL DUE TO A SENSE OF

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 13584013 ↗
• InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOI (B)(6) 2014: THE INFECTION WAS CLEARED AND AN LPS DISTAL FEMUR, SEGMENT COMPONENT, SLEEVE ADAPTOR, FEMORAL SLEEVE, LPS TIBIAL HINGE INSERT, UNIVERSAL STEM, MBT TRAY, MBT SLEEVE, AND UNIVERSAL STEM (SEE ADDITIONAL INFORMATION PROVIDED WITH PART/LOT) WAS IMPLANTED. A FREE LATISSIMUS DORSI FLAP WITH VEIN GRAFTING TO CORRECT A LEFT KNEE SKIN DEFECT PRESENT BEFORE THE REVISION WAS ALSO PERFORMED. POSTOPERATIVELY, THE DEVELOPED ACUTE RENAL FAILURE REQUIRING INCREASING IV FLUIDS. THIS WAS CAPTURED IN (B)(4). (B)(6) 2014: THE LATISSIMUS DORSI FLAP IS POSITIVE FOR PSEUDOMONAS AND STENOTROPHOMONAS MALTOPHILIA REQUIRING IV ANTIBIOTICS AND A WOUND VAC DRESSING TO ADDRESS THE DRAINAGE. THE INFECTION IS CLEARED THOUGH THE PATIENT IS TOLD TO REMAIN ON CHRONIC ANTIBIOTICS. DOI: (B)(6) 2014; DOE: (B)(6) 2014; AFFECTED KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13535288 ↗
• InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOI (B)(6) 2014: THE INFECTION WAS CLEARED AND AN LPS DISTAL FEMUR, SEGMENT COMPONENT, SLEEVE ADAPTOR, FEMORAL SLEEVE, LPS TIBIAL HINGE INSERT, UNIVERSAL STEM, MBT TRAY, MBT SLEEVE, AND UNIVERSAL STEM (SEE ADDITIONAL INFORMATION PROVIDED WITH PART/LOT) WAS IMPLANTED. A FREE LATISSIMUS DORSI FLAP WITH VEIN GRAFTING TO CORRECT A LEFT KNEE SKIN DEFECT PRESENT BEFORE THE REVISION WAS ALSO PERFORMED. POSTOPERATIVELY, THE DEVELOPED ACUTE RENAL FAILURE REQUIRING INCREASING IV FLUIDS. DOE: (B)(6) 2014.

  Patient problems: Renal Failure

  MAUDE report 13535079 ↗
• InjuryFeb 15, 2022Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN KNEE SIDE.

  Patient problems: Ambulation or Postural Difficulties; Fall; Inadequate Osseointegration; Pain; Scar Tissue; Unspecified Infection

  MAUDE report 13534864 ↗
• 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 13446136 ↗
• InjuryJan 18, 2022Fracture; Osseointegration Problem; Fracture; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE ER WITH PAIN. X-RAYS SHOWED BROKEN PROSTHESIS AT THE FEMORAL SLEEVE-STEM JUNCTION. THE FEMORAL SLEEVE APPEARED TO NOT HAVE INGROWN CAUSING FATIGUE FAILURE AT THE JUNCTION AS THE STEM WAS TIGHT INTO THE FEMORAL CANAL. SO, THE PIN WAS REMOVED AND THE NEW PIN THAT COMES WITH EVERY NEW FEMUR WAS USED. LOOSENING WAS NOTED OF AN UNKNOWN NON CEMENTED COMPONENT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2019; DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 13279701 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION TKA AFTER AN INFECTION WITH A TC3 IMPLANTS PLACED ON (B)(6) 2020. SHE WAS RETURNED TO SURGERY TODAY DUE TO A REPEAT KNEE INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. ADDITIONAL PART USED AND REMOVED, NOT RETURNED (B)(4). DOI: (B)(6) 2020, DOR: (B)(6) 2021, (RIGHT KNEE).

  Patient problems: Unspecified Infection

  MAUDE report 13043516 ↗
• InjurySep 16, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AT THE IMPLANT TO BONE INTERFACE. NO SURGICAL DELAY. DOI: (B)(6) 2017. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12480802 ↗
• InjurySep 10, 2021Osseointegration Problem; Osseointegration Problem

  COMPASS CASE (B)(4) REPORTS: THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AND THE FEMORAL SLEEVE AT THE BONE TO IMPLANT INTERFACE. PATIENT HAD A LEFT DISTAL FEMORAL REPLACEMENT ON (B)(6) 2019 AFTER HISTORY OF FAILED HARDWARE PLATE AND SCREWS OF THE FEMUR. IT WAS REVISED FOR LOOSE SLEEVE COMPONENT AND FRACTURE OF THE STEM SLEEVE JUNCTION. THE STEM WAS WELL FIXED WITH FRACTURE AT THE THREADED PORTION OF THE STEM, LEAVING BEHIND THE THREADS OF THE STEM IN THE SLEEVE. THE SLEEVE AND FEMORAL CONSTRUCT WERE LOOSE AND REMOVED AS WELL WAS THE POLY. THE TIBIA WAS RETAINED AS WELL AS THE PATELLA COMPONENT OF THE LEFT KNEE. NO DELAY IN SURGERY. DOI: (B)(6) 2019, DOR: (B)(6)2021, LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12454028 ↗
• 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 11796213 ↗
• InjuryMay 7, 2021Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO WITH ONSET IN PAIN AND LOOSENING OF THE FEMORAL SLEEVE AT THE BONE TO IMPLANT INTERFACE. X-RAYS REVEAL A BROKEN PROSTHESIS. PATIENT HAD A VERY TIGHT FEMORAL CANAL MAKING SURGEON BELIEVE THE STRESS WAS TRANSFERRED TO THE STEM AND LITTLE TO THE SLEEVE. AS SUCH, THE SLEEVE DID NOT IN GROW AND THE PROSTHESIS EVENTUALLY FAILED UNDER CYCLIC LOAD. PROSTHESIS WAS REMOVED AND REPLACED EVENTUALLY. DOI: (B)(6) 2020 DOR: (B)(6) 2021 RIGHT KNEE. FURTHER INFORMATION PROVIDED THAT THE STEM BROKE AT THE STEM-SLEEVE JUNCTION.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 11792246 ↗
• 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 11527283 ↗
• InjuryJan 20, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED BECAUSE THE JUNCTION BETWEEN THE FEMORAL SLEEVE AND THE 18MM STEM BROKE. LOOSENING WAS ALSO REPORTED AT BONE TO IMPLANT INTERFACE. IT IS BELIEVED TO BE INFECTED CAUSING FEMORAL SLEEVE TO NOT IN-GROW. EVERYTHING WAS TAKEN OUT AND RE IMPLANTED. NO DELAY TO SURGERY REPORTED. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11202018 ↗