NA 86-7418Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 10603295217848), received between Jun 26, 2017 and Aug 7, 2026 — classified as 81 injuries.

The most frequently reported specific device problem is “Fracture” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Loss of or Failure to Bond

  Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. Darthmouth is the research location, and not the facility of placement. A DePuy Synthes Implant was revised and reviewed for analysis. Reason for revision: Revision due to unspecified loosening and instability. The non-articular surface of the cemented CC femoral component shows moderate cement remaining.The non-articular surface of the cemented tibial tray shows abundant cement remaining.

  Patient problems: Joint Laxity

  MAUDE report 50180014 ↗
• InjuryMar 19, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT INITIAL TKA WAS UNKNOWN. DR DID THE FIRST REVISION BACK ON (B)(6) 2013 AT HOSPITAL. THERE WAS A LOOSENING BUT LOOSENING INTERFACE WAS UNKNOWN AND CEMENT MANUFACTURER WAS DEPUY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24637573 ↗
• InjuryJan 15, 2026Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT IN THE FEMUR FOLLOWING A REVISION TOTAL KNEE ARTHROPLASTY. X-RAYS REVEALED LUCENCY AROUND THE FEMORAL SLEEVE AND REMODELING IN THE FEMUR AROUND THE STEM, SUGGESTING LOOSE COMPONENTS. THE TIBIAL COMPONENTS APPEARED TO BE WELL FIXED AND SLEEVE APPEARED TO BE INGROWN. A FEMORAL SIDE REVISION WAS PERFORMED WITH NO DELAY AND NO PATIENT HARM. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort; Inadequate Osseointegration

  MAUDE report 24082019 ↗
• 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 23992690 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION OF LEFT KNEE DUE TO INSTABILITY. TC3/MBT IN SITU, TC3 REMOVED AND S-ROM HINGE IMPLANTED. TC3 POLY WAS WORN AND POLY SPINE FRACTURED. SIZE 5 LEFT TC3 FEMORAL COMPONENT. NO ALLEGATIONS AGAINST THE TIBIAL TRAY.

  Patient problems: Joint Laxity

  MAUDE report 22580670 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH POOR PATELLAR TRACKING AND WAS SCHEDULED FOR SURGERY TO ADDRESS. AFTER EXPOSURE, SURGEON NOTED THE FEMORAL COMPONENT APPEARED TO BE INTERNALLY ROTATED. WHILE EXTRACTING THE FEMORAL COMPONENT HE NOTICED THAT THE FEMORAL SLEEVE ALSO MOVED INDICATING THAT IT HAD NOT YET INGROWN. THIS LED THE SURGEON TO BELIEVE THAT THE PATIENT COULD STILL BE INFECTED AS HE WAS TREATED AT THE PREVIOUS SURGERY WITH A ONE STAGE REVISION FOR INFECTION. FROZEN SECTION WAS SENT TO PATHOLOGY AND SHOWED 5 WHITE CELLS/ HIGH POWERED FIELD. THIS RESULT WAS MORE INDICATIVE OF A LOOSE COMPONENT THAN INFECTION BUT SURGEON FELT COMPELLED TO PROCEED AS IF INFECTED AND ALSO SENT CULTURES. FEMORAL COMPONENTS WERE REMOVED AND A THOROUGH DEBRIDEMENT AND IRRIGATION WAS PERFORMED. FEMUR WAS THEN PREPARED FOR NEW COMPONENTS AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. NO DELAY WAS ENCOUNTERED AND NO PATIENT HARM NOTED. PATELLAR TRACKING AND MOTION WERE FOUND TO BE IMPROVED WITH NEW COMPONENTS IN PLACE. THERE WAS LOOSENING REPORTED AT NON-CEMENTED INTERFACE AT FEMORAL SLEEVE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 21952679 ↗
• 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 21883449 ↗
• InjuryDec 27, 2024Adverse 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 Q4 OF 2024.DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO INSTABILITY AND PAIN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 21026983 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC PAIN. PATIENT SEEN IN ED WITH DISLOCATED KNEE. CORRECTIVE SURGERY HAD MASSIVE METALOSIS, OSTEOLYSIS, AND POLYETHYLENE WEAR. SURGICAL DELAY UNKNOWN. ACTIVITY LEVEL: YES. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 20279442 ↗
• InjuryAug 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANTED DEVICES BROKE AT JUNCTION BETWEEN FEMORAL SLEEVE AND FEMORAL STEM. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19959969 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE PATIENT WAS FOUND TO BE REINFECTED, AFTER A 2-STAGE REVISION TKA. ALL COMPONENTS WERE REMOVED AND A THOROUGH DEBRIDEMENT WAS PERFORMED. A SPACER WAS PLACED USING LPS COMPONENTS, INCLUDING THE PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS AND COATING THE PROSTHESIS WITH HIGH-DOSE ANTIBIOTIC CEMENT. NO DELAY OR PATIENT HARM WAS NOTED. THERE WAS NO ALLEGATION AGAINST ANY DEPUY COMPONENT. THEY WERE SIMPLY REMOVED, DUE TO INFECTION. DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19928220 ↗
• InjuryApr 24, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: PAIN AND LOOSE (UNKNOWN COMPONENTS OR INTERFACE). AT REVISION THE BORE OF THE FEMORAL COMPONENT SHOWED FRETTING.

  Patient problems: Pain

  MAUDE report 19174764 ↗
• InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISING DUE TO NICKEL ALLERGY. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18571033 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN UNDISCOVERED NICKEL ALLERGY. THEY HAD PAIN THROUGHOUT THEIR LEG, SO THE SURGEON REPLACED EVERYTHING WITH COMPETITOR IMPLANTS. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE : UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 18184773 ↗
• InjuryOct 17, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PRE-OP DIAGNOSIS WAS ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. THE PATIENT REPORTEDLY ORIGINALLY HAD A DISTAL FEMORAL FRACTURE, FOLLOWED BY A PRIMARY TKA, FOLLOWED BY A REVISION TKA. THE TIMEFRAMES & FURTHER SPECIFICS WERE UNKNOWN. THE TC3 FEMORAL COMPONENT ALONG WITH THE AUGMENTS & STEM EXTENSION WERE FOUND TO BE LOOSE. LOOSENING INTERFACE WAS BONE/CEMENT AND CEMENT MANUFACTURER WAS UNKNOWN. CULTURES RUN INTRA-OPERATIVELY FOR INFECTION WERE REPORTEDLY NEGATIVE. THE MBT REV TRAY W/SLEEVE & STEM REMAINED WELL-FIXED & THUS LEFT IN PLACE. THE FEMUR WAS REVISED TO AN LPS DFR W/A CEMENTED STEM ALONG W/AN LPS ART SURFACE. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17948810 ↗
• InjurySep 19, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN. ONCE SURGEON FLEXED THE KNEE, THE FEMUR FELL OFF. THE FEMORAL ADAPTER BOLT BROKE. HAD TO REMOVE STEM & SLEEVE AND PUT IN A NEW STEM AND SLEEVE WITH A TC3 FEMUR. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17774602 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS EXPLANTED TC3 CONSTRUCT DUE TO NICKEL ALLERGY. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17490556 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INSTABILITY. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17046972 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. IMPLANTS WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16246207 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON STATED PATIENT WAS UNSTABLE. THE SURGEON REMOVED THE FEMORAL COMPONENTS/POLY AND REPLACED FEMORAL COMPONENTS/POLY. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15910492 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION PRESENT WITHIN KNEE. CONVERTED TO ABX SPACER. IT IS UNKNOWN IF ANY LOOSENING. THERE IS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2021. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14514287 ↗
• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOE: (B)(6) 2020 - (B)(6) 2022: PATIENT CONTINUED TO HAVE CHRONIC RIGHT KNEE PAIN, WALKING DIFFICULTY, REDUCED ROM, AND SWELLING AFTER REVISION. PATIENT RECEIVED A RIGHT KNEE ULTRASOUND WITH ASPIRATION AND CORTICOSTEROID INJECTION COMBINED WITH CONTINUED PHYSICAL THERAPY, WHICH WAS INEFFECTIVE. BETWEEN (B)(6) 2020 AND (B)(6) 2022, THE PATIENTS PAIN MANAGEMENT PHYSICIAN ADMINISTERED 7 KETAMINE INFUSIONS TO TREAT HIS RIGHT KNEE CHRONIC REGIONAL PAIN SYNDROME (CRPS). THE PATIENT ALSO RECEIVED A RIGHT KNEE GENICULAR NERVE RADIOFREQUENCY ABLATION (RFA) ON (B)(6) 2022. THERE WERE NO ALLEGATIONS OF PRODUCT DEFECTS NOR WERE THERE ANY REVISION SURGERIES PERFORMED. ALL PROCEDURES WERE ADMINISTERED TO TREAT THE PATIENTS ONGOING CHRONIC PAIN, SWELLING, REDUCED ROM, AND WALKING DIFFICULTY AND WILL BE CAPTURED AS ONE EVENT DOI: (B)(6) 2019 (TIBIAL TRAY). (B)(6) 2019 (TIBIAL INSERT). (B)(6) 2020 (FEMORAL COMPONENT). DOE: (B)(6) 2020.

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 14317279 ↗
• 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 14103934 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED AN I& D WITH A REVISION OF THE LEFT KNEE LPS HINGED INSERT TO TREAT PAIN AND SWELLING SECONDARY TO MRSA INFECTION. THE PATIENT WAS PLACED ON IV ANTIBIOTICS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2015 . DOR: (B)(6) 2016 . (LEFT KNEE).

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 13567749 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRA-OP EVENT OF SIGNIFICANT BLEEDING AT THE POSTEROLATERAL SIDE FROM THE POPLITEAL ARTERY AND THIS BLEEDING WAS STOPPED BY PACKING AND THE USE OF VASCULAR CLIPS, TOTAL BLOOD LOSS WAS 500 ML.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13558738 ↗