NA 1294-35-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10603295025986), received between Mar 29, 2018 and Aug 7, 2026 — classified as 27 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (4 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 28 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Loss of or Failure to Bond

  (b)(6) at (b)(6) first report of retrievals for Statement of Work 10 for Q2 of 2026. (b)(6) 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 loose tibia. The non-articular surface of the cemented tibial tray shows moderate cement remaining. Loosening interface not included.

  Patient problems: Insufficient Information

  MAUDE report 50173743 ↗
• InjuryAug 1, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TC3 TIBIA W/ STEM AND SLEEVE AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS REPORTED THAT THE PATIENT¿S KNEE BECAME SEPTIC AND TIBIAL CONSTRUCT BECAME LOOSE. THE FEMUR, TIBIAL CONSTRUCT, POLY, AND PATELLA WERE EXTRACTED. PATELLA WAS NOT LISTED IN THE LIST OF IMPLANTS FROM INITIAL SURGERY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22687548 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2025. (B)(6) 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 22666373 ↗
• 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 21883011 ↗
• 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: ON (B)(6) 2020, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20440002 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RETURNED TO SURGERY FOR AN INFECTED LEFT HINGE KNEE. ALL COMPONENTS WERE REMOVED AND A STATIC SPACER WAS PLACED. THERE WERE NO SURGICAL DELAYS, DEFICIENCIES OR BROKEN INSTRUMENTS. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17135020 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT RECEIVED A LCS KNEE SOME TIME AGO (NO DETAILS AVAILABLE OF INITIAL OPERATION. BEING REVISED TO A 1ST STAGE SPACER FOR INFECTION. NO FURTHER DETAILS AVAILABLE. IF OTHER, DESCRIBE INFECTION., IF OTHER, DESCRIBE 1ST STAGE REVISION TO TEMPORARY SPACER - INFECTION, PATIENT STATUS/ OUTCOME / CONSEQUENCES YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? INFECTION, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE -REVISION SURGERY, OTHER INFORMATION N/A, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF -ONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDIT

  Patient problems: Unspecified Infection

  MAUDE report 15939809 ↗
• InjuryJan 24, 2022Migration; Migration

  THE PATIENT WAS REVISED DUE TO TIBIA COLLAPSED ON THE MEDIAL SIDE AND CAUSED PATIENT DISCOMFORT AND INSTABILITY. THE DOCTOR REMOVED ALL COMPONENTS AND REPLACED WITH A NEW REVISION KNEE TO CORRECT PATIENTS INSTABILITY. DOI : (B)(6) 2008. DOR : (B)(6) 2022. LEFT SIDE.

  Patient problems: Discomfort; Joint Laxity

  MAUDE report 13335012 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISE DUE TO INFECTION AND LOOSENING OF THE FEMUR AND TIBIA COMPONENT AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. ALL COMPONENTS ARE BEING REMOVED AND A CEMENT SPACER IS BEING IMPLANTED. PATIENT FIRST REIMPLANTATION USING DEPUY PRODUCTS WAS ON (B)(6) 2020. INCLUDED THE PARTS FROM WHICH NUMBERS COULD BE OBTAINED. THE KNEE HAS AUGMENTS, STEMS AND SLEEVES FROM WHICH NUMBERS COULD NOT BE OBTAINED. PATIENT HAD A POLY EXCHANGE ON (B)(6) 2021. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2020 (FEMUR, TIBIA, AUGMENTS, SLEEVE & STEM), (B)(6) 2021 (TIBIAL INSERT); DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12632449 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND SWELLING. KNEE WAS INFECTED AND REMOVED IMPLANTS. INSERTED ANTIBIOTIC SPACER WAS DONE. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2016 (FEMORAL, PATELLA AND TIBIAL TRAY), (B)(6) 2019 (TIBIAL INSERT); DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Swelling/ Edema

  MAUDE report 12438810 ↗
• InjuryJul 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS REVISED FOR COMPLAINTS OF PAIN WITH SUSPECTED INFECTION, NOT BEING CONFIRMED INTRAOPERATIVELY.

  Patient problems: Fall; Joint Laxity; Pain

  MAUDE report 12180231 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS LACK OF FLEXION AND EXCESSIVE SCAR TISSUE. NO SURGICAL DELAY. DOI: (B)(6) 2003, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11879308 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OFFICE NOTES ''(B)(6) 201'' - (B)(6) 2019 INDICATE THE PATIENT IS EXPERIENCING SWELLING, POPPING, INSTABILITY AND PAIN OF THE LEFT KNEE. HE IS ALSO EXPERIENCING SWELLING, PAIN, NUMBNESS AND INSTABILITY IN THE RIGHT KNEE AND FEELINGS OF CRUNCHING AND CRACKING. CURRENT TREATMENT INCLUDES ORAL PAIN MEDICATION, PHYSICAL THERAPY, KNEE BRACES AND NERVE BLOCKS. NO EVIDENCE OF ADDITIONAL REVISION OF PRODUCTS. DOI: ''(B)(6) 201'' (TRAY - CAPTURED IN (B)(4)). DOI: (B)(6) 2019 (FEMUR, PATELLA AND INSERT - CAPTURED IN (B)(4)). DOR: NONE REPORTED; RIGHT KNEE.

  Patient problems: Joint Laxity; Numbness; Pain; Swelling/ Edema

  MAUDE report 11728130 ↗
• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2004, THE PATIENT UNDERWENT A BILATERAL KNEE ARTHROPLASTY DUE TO ARTHRITIS. DEPUY PRODUCTS WERE IMPLANTED IN BOTH KNEES. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2011, THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS INFECTION, COMPARTMENT SYNDROME, DISLOCATION, INSTABILITY, AND ABSCESS. ALL COMPONENTS WERE NOTED TO BE REMOVED AND REPLACED WITH ARTICULATING ANTIBIOTIC SPACER. UNKNOWN MANUFACTURER PRODUCTS WERE IMPLANTED DURING THE REVISION.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Dislocation

  MAUDE report 11334384 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS FROM (B)(6) 2020 NOTE THAT THE PATIENT WENT THE ER DUE TO WORSENING LEFT KNEE PAIN AND GOT AN INJECTION OF TORADOL. DOI: (B)(6) 2016, DOR: (B)(6) 2017 (CAPTURED IN (B)(4)), DOE: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10582957 ↗
• InjuryJul 17, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  ASEPTIC LOOSENING OF A DEPUY REVISION TIBIAL TRAY AND SLEEVE.

  Patient problems: No Code Available

  MAUDE report 10289877 ↗
• 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 9874271 ↗
• InjuryJan 29, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS THE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS AT THE CEMENT TO THE IMPLANT INTERFACE. UNKNOWN BONE CEMENT WAS USED. IT IS ALSO UNKNOWN WHERE OR WHO DID THE PREVIOUS SURGERY AND LOT #S COULD NOT BE FOUND FOR ALL PRODUCTS THAT WERE REMOVED AND AS WELL AS THE PART NUMBER OF THE POLY THAT WAS REMOVED. THE PATELLA WAS LEFT IN PLACE. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9641494 ↗
• InjuryDec 6, 2019Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration

  THE PATIENT WAS REVISED DUE TO TIBIAL SUBSIDENCE AND SUBSEQUENT LOOSENING AT THE BONE TO CEMENT INTERFACE. ALL COMPONENTS WERE REMOVED AND REPLACED. COMPETITOR BONE CEMENT WAS USED. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9429561 ↗
• InjurySep 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTED LEFT TOTAL KNEE. DOI: (B)(6) 2018; DOR: (B)(6) 2019 LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9135794 ↗
• MalfunctionSep 27, 2019Unintended Movement; Migration; Unintended Movement; Migration

  CLINICAL ADVERSE EVENT RECEIVED FOR TIBIAL SUBSIDENCE MEDIUM LONG TERM : ABNORMAL RADIOGRAPHIC EVALUATION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2016. DATE OF REVISION #1: (B)(6) 2016. DATE OF REVISION #2: (B)(6) 2016. DATE OF EVENT: (B)(6) 2019. (RIGHT KNEE).

  Patient problems: Ambulation or Postural Difficulties; No Consequences Or Impact To Patient; Pain; Unspecified Infection; Weakness

  MAUDE report 9129141 ↗
• InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT LOWER EXTREMITY SUPERFICIAL THROMBOSIS AND CELLULITIS - REDNESS AND SWELLING. ONSET OCCURRED A FEW DAYS AFTER PRIMARY IMPLANT SURGERY. DOI: (B)(6) 2012 (LEFT KNEE).

  Patient problems: Cellulitis; Swelling; Thrombosis

  MAUDE report 8653988 ↗
• InjuryMay 7, 2019Malposition of Device; Malposition of Device

  PATIENT WAS REVISED DUE TO ASEPTIC FAILURE. DOI: (B)(6) 2017; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8588168 ↗
• InjuryJan 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8222382 ↗
• InjuryDec 26, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND LOOSENING OF THE TIBIAL COMPONENT AT AN UNKNOWN INTERFACE.

  Patient problems: No Code Available

  MAUDE report 8195781 ↗