NA 1294-35-130Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 10603295025962), received between Aug 31, 2017 and Apr 24, 2026 — classified as 75 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (18 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 77 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT SEPTIC A LOOSENING. IT WAS STATED THAT FEMUR/TIBIA WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS UNKNOWN. DOI: ON (B)(6) 2017, DOR: ON (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 24981413 ↗
• InjuryJul 30, 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 TIBIAL SLEEVE, TIBIAL STEM, TIBIAL TRAY, AND TIBIAL INSERT WERE REVISED FOR INSTABILITY AND PAIN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22668243 ↗
• InjuryJan 17, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING. THE LOOSENING WAS AT THE NON-CEMENTED INTERFACE. DEPUY CEMENT WAS USED. DOI: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21181142 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE KNEE HYPEREXTENDED. DOI: (B)(6) 2019. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Joint Laxity

  MAUDE report 19313011 ↗
• InjuryMay 7, 2024Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED. A. PLEASE CONFIRM, WHAT IMPLANTS WERE MISPOSITIONED. FEMORAL COMPONENT AND TIBIAL TRAY. B. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? NO, DUE TO THE MISPOSITIONING OF THE IMPLANTS. C. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO. D. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY, THAT LED TO THE INSTABILITY? NO, ALL CORRECT SIZING. E. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED, DURING THE PRIMARY SURGERY, THAT LED TO THE INSTABILITY? NO, REPORTED AS OKAY. F. WAS THERE A SURGICAL DELAY, BECAUSE OF THIS EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? NO.

  Patient problems: Joint Laxity

  MAUDE report 19261607 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: INSTABILITY, PAIN. AT REVISION THE BORE OF THE FEMORAL STEM SHOWED FRETTING. THE TRUNNION SHOWS SEVERE CORROSION.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19201454 ↗
• InjuryDec 22, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT WAS PRESENTED WITH KNEE PAIN. THERE WAS NO INDICATION OF ANY INFECTION. SURGEON OPENED UP KNEE AND FOUND TIBIA AND TIBIAL SLEEVE WERE LOOSE. SURGEON REMOVED TIBIA AND SLEEVE CONSTRUCT AND REMOVED FEMUR FOR BETTER KNEE ACCESS. SURGEON LEFT FEMORAL STEM AND SLEEVE AS IT WAS WELL FIXED. SURGEON OPTED TO RE IMPLANT DJO CONE AND NEW TC3 FEMUR AND MBT TRAY AND CEMENTED STEM. (B)(6). AFFECTED SIDE: LEFT KNEE

  Patient problems: Pain

  MAUDE report 18382944 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL TIBIA. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 18138722 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE. NO DELAY. DOI- (B)(6) 2020. DOR- (B)(6) 2023. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18121082 ↗
• InjuryNov 8, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT HAS A LEFT TOTAL SIGMA KNEE WITH A LOOSE TIBIAL TRAY. THE SURGEON REVISED THE TIBIAL TRAY AND RETAINED THE WELL FIXED FEMUR AND PATELLA. THE TIBIAL SLEEVE DID NOT SEEM TO INGROW ON THE CONSTRUCT. DOI: (B)(6) 2021; DOR: (B)(6) 2023; AFFECTED SIDE : LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18096607 ↗
• InjuryAug 15, 2023Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  CLINICAL NOTES RECEIVED. (B)(6) 2016, THE PATIENT HAD A REVISION LEFT TOTAL KNEE TO ADDRESS FAILED TIBIAL COMPONENT LEFT TOTAL KNEE. DURING THE PROCEDURE, THE SURGEON OBSERVED THAT THE TIBIAL TRAY WAS GROSSLY LOOSE AT THE CEMENT/TIBIAL TRAY INTERFACE. THE COMPONENTS THAT WERE IMPLANTED WHERE DEPUY PRODUCTS, INCLUDING A DEPUY PATELLA. MEDICAL RECORDS FROM (B)(6) 2018 NOTE THE PATIENT HAS A PAINFUL LEFT KNEE. THE SURGEON¿S IMPRESSION IS THAT THAT PATIENT HAS A WELL FIXED KNEE WITH GREAT RANGE OF MOTION. THERE WAS SOME MILD SYNOVIAL ENTRAPMENT, WHICH IS NOT PAINFUL. THE SURGEON NOTED THAT THE PAIN WAS MOST LIKELY REFERRED FROM LEFT HIP AND WOULD BENEFIT FROM A LEFT HIP REPLACEMENT. (NO NEW PC REQUIRED AT THIS TIME, AS THE PAIN IS BEING ATTRIBUTED TO THE PATIENT¿S NATIVE LEFT HIP).

  Patient problems: Pain

  MAUDE report 17549547 ↗
• InjuryAug 4, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT HAD PRIMARY TKR AND HAS HAD ONGOING ISSUES SINCE WITH PAIN, SWELLING AND LOOSENING. PATIENT HAD A PARTIAL REVISION FOR PAIN AND LOOSENING. PATIENT PRESENTED AGAIN WITH PAIN AND BONE SCANS SUGGESTING LOOSENING. REVISED ENTIRE CONSTRUCT. PRESENTED AGAIN WITH PAIN. BONE SCAN SUGGESTED LOOSENING SO REVISED TO ATTUNE REVISION WITH STEMS AND SLEEVES. IMPLANTS WEREN'T GROSSLY LOOSE AND REQUIRED SOME WORK (FLEXIBLE OSTEOTOMES AROUND METAPHYSEAL SLEEVES AND SLAP HAMMER ATTACHMENTS) TO REMOVE. DOI: (B)(6) 2017. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 17459445 ↗
• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SEVERE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2010. DATE OF REVISION: (B)(6) 2013. DATE OF EVENT: (B)(6) 2011. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL BASE, AND INSERT WERE REVISED.

  Patient problems: Pain

  MAUDE report 17412556 ↗
• InjuryMay 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  FOLLOWING THE DISLOCATION OF A MASSIVE LPS TKA, THE SURGEON NOTED DURING THE REVISION THAT DAY THAT THE INSERT WAS SEPARATED FROM ITS POLYETHYLENE PART TO ITS METAL PART. THE SURGEON WONDERS IF THIS OBSERVATION IS NOT THE CAUSE OF THE DISLOCATION OF THE PROSTHESIS. CONSEQUENCE: REOPERATION OF THE PATIENT WITH CHANGE OF THE DISTAL FEMUR + SEGMENT + KEEL + INSERT.

  Patient problems: Joint Dislocation

  MAUDE report 16952825 ↗
• InjuryFeb 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2020. DATE OF REVISION: (B)(6) 2022. (RIGHT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, AND INSERT WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 16301899 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16214056 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TC3 REVISION KNEE ? INFECTED - UNSTABLE SIGNASURE CAME BACK NEGATIVE FOR INFECTION PREVIOUS IV DRUG ABUSER, HIGH FUNCTIONING KNEE PLAN A- ATTUNE REVISION, PLAN B - ATTUNE HINGE, PLAN C - TC3 FEMUR REVISION IF TIBIA WELL FIXED. IN SITU - TC3FEMUR SIZE 4 PLUS DISTAL AND POSTERIOR AUGMENTS, STEM AND ADAPTOR, MBT TIBIA REVISION SIZE 3, WEDGE, STEM, SIZE 4 20MM INSERT TC3 RP, PATELLA 41MM 3 PEG,

  Patient problems: Joint Laxity

  MAUDE report 16019469 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAINFUL RIGHT KNEE. DOI: (B)(6) 2016, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15586755 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERI-PROSTHETIC TIBIA FRACTURE AROUND A DEPUY TKA. DOI: (B)(6) 2012; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 15249598 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH A PAINFUL KNEE AND SCANS SHOWED THE IMPLANT WAS LOOSE BOTH THE FEMUR AND THE TIBIA AND THE PATIENT WAS EXPERIENCING INSTABILITY. NO INFECTION WAS FOUND. DOI: (B)(6) 2019. DOR: (B)(6) 2022. LEFT SIDE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 14985779 ↗
• InjuryMay 5, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD FEMORAL REVISION ON (B)(6) 2022 FOR A DISLOCATED POLY ALSO. FEMORAL SIDE IMPLANTS WERE PLACED AT THAT TIME TO INCLUDE THE INSERT. TIBIAL COMPONENTS WERE PLACED AT THE ABOVE LISTED DATE. PATIENT PRESENTS WITH A DISLOCATED POLY AGAIN. TIBIAL SIDE REVISION WAS PERFORMED AS SURGEON BELIEVES HIS PATELLA TENDON HAS NOW SHORTENED TO THE POINT THAT THE JOINT LINE IS NOW INCORRECT LEADING TO THE RECURRENT DISLOCATIONS. CEMENT WAS LIKELY A DEPUY PRODUCT BUT WOULD HAVE BEEN HOSPITAL INVENTORY SO NO LOT OR QUANTITY INFORMATION IS AVAILABLE. THE PIN WAS CHANGED TO THE ONE THAT CAME WITH THE NEW DISTAL FEMORAL COMPONENT. DOI- (B)(6) 2022; DOR- (B)(6) 2022; AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Dislocation; Joint Laxity; Muscle/Tendon Damage

  MAUDE report 14287288 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF LCS REVISION BECAUSE OF PAIN AND STIFFNESS - REVISED TO A HINGE FROM ANOTHER COMPANY. DOI: (B)(6) 2019. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 13769527 ↗
• InjuryMar 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO KNEE INFECTION. THERE WAS NO WAY TO CONFIRM THE INFECTION. NO SURGICAL DELAY. DOI : (B)(6) 2018; DOR : (B)(6) 2022; AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13659126 ↗
• 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 (B)(6) 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 13567753 ↗
• InjuryDec 3, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO FELL COMING OUT ON HIS SHOWER AND LOOSENING OF THE TIBIA COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2018 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Fall

  MAUDE report 12924058 ↗