NA 1294-53-246Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10603295026365), received between Jun 26, 2017 and Jan 15, 2026 — classified as 36 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (5 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 37 reports, in the reporter's own words as published by the FDA.

• 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 24082012 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ PAIN/STIFFNESS DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: NO INFORMATION PROVIDED PROCEDURE RELATED: NO INFORMATION PROVIDED DATE OF EVENT: 15 SEP 2025 DATE OF IMPLANT: NO INFORMATION PROVIDED DATE OF REVISION: (B)(6) 2025 DEVICE LOCATION. TREATMENT/IMPACT: WERE DEPUY SYNTHES COMPONENTS REMOVED (FEMORAL), SYNOVECTOMY.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 23326316 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ PAIN/STIFFNESS DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: NO INFORMATION PROVIDED PROCEDURE RELATED: NO INFORMATION PROVIDED DATE OF EVENT: 15 SEP 2025 DATE OF IMPLANT: NO INFORMATION PROVIDED DATE OF REVISION: (B)(6) 2025 DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: DEPUY SYNTHES COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL), SYNOVECTOMY.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 23325045 ↗
• InjuryMay 2, 2025Osseointegration Problem; Osseointegration 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: Inadequate Osseointegration; Joint Laxity; Unspecified Infection

  MAUDE report 21952649 ↗
• MalfunctionNov 7, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE ITEM ARRIVED WITH BROKEN PLASTIC COVER FROM THE EDC TO THE DISTRIBUTOR'S WAREHOUSE. THE ITEM WAS NOT SHIPPED TO ANY CUSTOMER/HOSPITAL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20632351 ↗
• InjurySep 13, 2023Difficult to Insert; Difficult to Insert

  FAILURE OF LPS MEDICAL RECORD WAS REVIEWED BY CLINICIAN. ON (B)(6) 2023, THE PATIENT WAS REVISED TO ADDRESS THE FEMORAL COMPONENT ROTATING AS THE DISTAL PART OF THE FEMORAL CONSTRUCT COULD ROTATE FREELY ON THE SLEEVE. THE SLEEVE AND SEGMENT COMPONENT REPORTED FOR IMPLANT TO IMPLANT FIT.

  Patient problems: Insufficient Information

  MAUDE report 17738946 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT FELL AND FRACTURED HIS DISTAL FEMUR BETWEEN HIS HINGED KNEE REPLACEMENT AND HIS PROXIMAL FEMORAL REPLACEMENT. WITH LITTLE BONE TO GAIN FIXATION BETWEEN THE IMPLANTS, THE SURGEON CHOSE TO CONVERT TO A TOTAL FEMUR. THE SURGERY WAS UNEVENTFUL AND NO PATIENT HARM OCCURRED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2018, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 16484851 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO SIGNIFICANT SCARRING AND HAD POOR QUAD FUNCTION. PATIENT HAS HAD MULTIPLE SURGERIES. PATIENT HAD A TC3 RP REVISION PLACED IN (B)(6) 2018, WHICH MANY ITEMS WERE REMOVED AND CONVERTED TO DISTAL FEMORAL REPLACEMENT ON (B)(6) 2021(FEMORAL SLEEVE AND STEM WERE RETAINED). FEMORAL SIDE WAS REVISED AND JOINT LINE WAS ELEVATED TO TRY TO ADJUST PATELLA POSITION AND IMPROVE QUAD FUNCTION. FEMORAL SIDE WAS UNCEMENTED. NO PATIENT HARM WAS OCCURRED. NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS RECEIVED. DOI: (B)(6) 2018, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Unspecified Tissue Injury

  MAUDE report 15587666 ↗
• InjuryOct 7, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT THE INITIAL PROCEDURE ON THE (B)(6) 2022 (RECEIVED AN S-ROM NOILES ROTATING HINGE KNEE). THE PATIENT FELT HIS KNEE "GIVE WAY", FOLLOWED BY SIGNIFICANT PAIN. UPON INVESTIGATION IT WAS DISCOVERED THAT THE "BOSS" FOR THE SLEEVE ATTACHMENT ON THE FEMORAL COMPONENT HAD BROKEN RESULTING IN FAILURE OF THE CONSTRUCT. THE PATIENT UNDERWENT REVISION SURGERY AND THE DAMAGED FEMORAL COMPONENTS WERE REMOVED AND REVISED TO AN LPS DISTAL FEMORAL REPLACEMENT. THE RETRIEVED IMPLANTS WERE SENT TO THE BIO-ENGINEERING DEPARTMENT AT ROYAL PERTH HOSPITAL AS PER STANDARD PROTOCOL HERE IN WA. IF OTHER, DESCRIBE N/A. IF OTHER, DESCRIBE REVISION KNEE SURGERY. PATIENT STATUS/ OUTCOME / CONSEQUENCES YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?--> PAIN, INFLAMMATION, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE X-RAYS, 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,

  Patient problems: Fall; Inflammation; Joint Laxity; Pain

  MAUDE report 15566597 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD IMPLANTS REMOVED AND REPLACED DUE TO SUSPECTED INFECTION. IMPLANTS WERE PLACED ON 2 DATES PER THE RECORDS, (B)(6) 2019(FIRST 5 ITEMS LISTED) AND (B)(6) 2022. PATIENT EXPERIENCED REPEATED EFFUSIONS. SURGEON HAS SENT MULTIPLE ASPIRATIONS BUT NO CULTURES WERE NOT POSITIVE. CELL COUNTS AND LAB VALUES WERE ELEVATED, BUT NOT REACHING A LEVEL TO DIAGNOSE INFECTION. DURING THE PROCEDURE, 2 SEPARATE TISSUE SAMPLES WERE SENT TO PATHOLOGY, AND 3 AND 4 WBC/HPF WERE FOUND, AGAIN ELEVATED BUT NOT DEFINITIVE. SURGEON CHOSE TO REMOVAL ALL COMPONENTS AND REPLACE IN A ONE STAGE FASHION AFTER A THOROUGH DEBRIDEMENT AND IRRIGATION. ANTIBIOTIC BEADS WERE PLACED IN CANALS AND SURROUNDING SOFT TISSUES AND VANCOMYCIN WAS ADDED TO GENT CEMENT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2019; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 15437267 ↗
• 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 14513981 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 14101647 ↗
• InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO ARTHROFIBROSIS. THERE WAS NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2011, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 12721275 ↗
• InjuryOct 15, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT'S FEMORAL SLEEVE DID NOT INGROW AND SUBSIDED. COMPONENTS WERE REMOVED AND NEW COMPONENTS WERE PLACED. THIS PATIENT HAS A BELOW KNEE AMPUTATION ON THE OPPOSITE LEG SO LIMITED WEIGHT BEARING IS NOT POSSIBLE LIKELY CONTRIBUTING TO LACK OF FIXATION. THERE WAS ALSO AN INDICATION OF LOOSENING WITH THE FEMORAL SLEEVE. DOI: (B)(6) 2021, DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12638334 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TKA. REMOVED IMPLANTS THAT WERE IMPLANTED (B)(6) 2020. PERFORMED WASHOUT, I&D AND IMPLANTED A ANTIBIOTIC CEMENT SPACER. DOI: (B)(6) 2020 DOR: (B)(6) 2021 LEFT KNEE.

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

  MAUDE report 12295697 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS TO CAPTURE PATIENTS¿ PRIOR REVISIONS REPORTED IN (B)(4). THIS WAS THE TENTH REVISION FOR THIS PATIENT; PATIENT UNDERWENT A LEFT PRIMARY TOTAL KNEE REPLACEMENT (TKR) ON (B)(6) 2009. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2020 DUE TO TIBIAL PAIN.

  Patient problems: Pain

  MAUDE report 12168026 ↗
• 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)96) 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 12041667 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL IMPLANT EXPLANTED, CONVERT TO ANTIBIOTIC SPACER DUE TO INFECTION. POLY INSERT CHANGED ON (B)(6) 2019 FROM PREVIOUS INFECTION. DOI: (B)(6) 2019 ALL EXPLANTED PRODUCTS. DOI: (B)(6) 2019 TIBIAL INSERT. DOR: (B)(6) 2021. RIGHT KNEE.

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

  MAUDE report 11917885 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION AND REMOVAL OF ALL PREVIOUS REVISION COMPONENTS. REVISION WAS REQUIRED DUE TO INFECTION BEING PRESENT WITH SWELLING AND FLUID WITHIN THE KNEE. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN KNEE.

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

  MAUDE report 11887186 ↗
• InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR COMPROMISE WITH SUBSEQUENT COMPARTMENT SYNDROME AND GRAFTING : INFECTION - DEEP. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2004; DATE OF EVENT (ONSET): (B)(6) 2010; (RIGHT KNEE); TREATMENT: REVISED ON (B)(6) 2011, ALL PRODUCTS EXPLANTED.

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

  MAUDE report 11354259 ↗
• 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 10986347 ↗
• InjuryNov 5, 2020Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED DUE TO LOOSENING OF THE SROM FEMUR AT THE BONE TO IMPLANT INTERFACE. POST OF SROM HINGE FEMORAL COMPONENT BROKE IN-SITU AND PART OF POST WAS STUCK IN UNIVERSAL FEMORAL SLEEVE. SURGEON BELIEVES IT BROKE UNDER PRESSURE. SURGEON HAD TO REMOVE FEMORAL SLEEVE AND PRESS FIT STEM. FEMUR WAS REVISED. DOI: (B)(6) 2017, DOR: 2020, LEFT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10792902 ↗
• InjuryJun 25, 2020Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  FRACTURE OF S-ROM NOILES FEMORAL STEM LEFT SIDE. DOI: 2017 IN ANOTHER HOSPITAL. DOR (PLANNED): (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 10198252 ↗
• 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 9874274 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DISTAL FEMORAL COMPONENTS REMOVED DUE TO INFECTION. LPS POLY AND HINGE PIN THAT WERE PLACED ON (B)(6) 2019 REMOVED, TIBIAL AND PATELLAR COMPONENTS REMOVED THAT WERE PLACED (B)(6) 2017. DOI: (B)(6) 2019 (FEMORAL COMPONENTS). DOI: (B)(6) 2019 (LPS POLY AND HINGE PIN). DOI: (B)(6) 2017 (TIBIAL AND PATELLA COMPONENTS). DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9379246 ↗