NA 1294-54-130Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295026440), received between Dec 14, 2017 and Jan 30, 2024 — classified as 13 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2024Migration; Migration

  ISSUES WITH SUBSIDENCE OF THE TIBIAL SLEEVE. THIS NOW MEANS THAT THE POLY IS TOO SMALL. I REQUIRE THIS TO BE FILLED OUT IN ORDER TO FACILITATE ORDERING OF A CUSTOM IMPLANT. PATIENT STATUS/ OUTCOME / CONSEQUENCES --> YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?--> CURRENT REDUCED FUNCTION DUE TO POLY NOW BEING SMALLER THAN REQUIRED., IS THE PATIENT PART OF A CLINICAL STUDY --> YES.

  Patient problems: Loss of Range of Motion

  MAUDE report 18606385 ↗
• 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 15586767 ↗
• 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). (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). (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 DECEMBER 2014: THE PATIENT SUSTAINS A FALL DUE TO A SENSE OF INSTA

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 13584014 ↗
• 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 13535259 ↗
• 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 13535102 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS INFECTION, PAIN, SWELLING, SYNOVITIS, REMOVAL OF FIBROUS TISSUE, AND TIBIAL COMPONENT LOOSENING. THE SURGEON HAD TO PERFORM A CORONAL PLANE OSTEOTOMY OF THE DISTAL FEMUR TO REMOVE THE WELL-FIXED FEMORAL COMPONENTS. THERE WAS NOTED TO BE REMOVAL OF CERCLAGE WIRES ON THE FEMUR THAT WERE PLACED PRIOR FOR AN UNKNOWN REASON ON AN UNKNOWN DATE. IT IS UNKNOWN IF THE WIRES WERE PREVIOUSLY PLACED DUE TO A COMPLICATION OR TO PREVENT ANY ISSUES.

  Patient problems: Adhesion(s); Pain; Swelling/ Edema; Synovitis; Unspecified Infection

  MAUDE report 12862919 ↗
• 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 12296752 ↗
• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION AND REMOVAL OF ALL PREVIOUS REVISION COMPONENTS. SALES REP LM WAS PRESENT AT THIS CASE, PLEASE FORWARD ANY FURTHER QUESTIONS TO HIM. REVISION WAS REQUIRED DUE TO INFECTION BEING PRESENT 11TH REVISION AND REMOVAL OF ALL PREVIOUS REVISION COMPONENTS TO TREAT LEFT KNEE SWELLING AND CONFIRMED INFECTION. PATIENT RECEIVED A TEMPORARY ATTUNE ANTIBIOTIC SPACER TO BE REMOVED WHEN THE INFECTION HAS CLEARED. DOI: (B)(6) 2020 (10TH REVISION AND IMPLANTATION OF REVISION PRODUCTS), DOR: (B)(6) 2021 (11TH REVISION AND REMOVAL OF ALL PRODUCTS), LEFT KNEE.

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

  MAUDE report 12149732 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2017; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11455667 ↗
• InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PREVIOUSLY, A DISTAL FEMUR REPLACEMENT HAD BEEN CARRIED OUT ON (B)(6) 2020 WITH ASEPTIC LOOSENING AND DESTRUCTION OF THE DISTAL FEMUR. DOI: UNKNOWN. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Dyspnea; Heart Failure; Low Blood Pressure/ Hypotension; No Code Available; Weakness

  MAUDE report 9925006 ↗
• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(4). ASSOCIATED STUDY: ROTATING PLATFORM KNEE. CLINICAL ADVERSE EVENT RECEIVED FOR INTRAOPERATIVE FEMORAL FRACTURE AND TIBIAL FRACTURES. EVENT IS SERIOUS AND IS CONSIDERED MODERATE IN SEVERITY. EVENT IS RELATED TO BOTH DEVICE AND PROCEDURE. DOI: (B)(6) 2018. DOE: (B)(6) 2018. (RIGHT KNEE). OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 8239371 ↗
• InjuryJan 3, 2018Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE BONE/IMPLANT INTERFACE. DOI: (B)(6) 2015. DOR: (B)(6) 2017. RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7159620 ↗
• InjuryDec 14, 2017Fracture; Fracture

  IT STATES THAT THE PATIENT WITH ABNORMAL GIGANTISM WILL UNDERGO REVISION BECAUSE OF FRACTURE OF S-ROM NOILES ROTATING HINGE KNEE STEM. UPDATE NOV 14, 2017 ADDITIONAL INFORMATION RECEIVED. CUSTOMER REPORTED TO (B)(6): CHANGE OF TIBIAL COMPONENTS OF KNEE-TEP ON (B)(6) 2011. IN (B)(6) 2017 A FRACTURE OF TAPER OF TIBIAL PART OF PROSTHESIS WAS SUSPECTED AFTER RADIOLOGICAL EXAMINATION. REVISION WITH CHANGE OF TIBIAL COMPONENTS ON (B)(6) 2017. INTRAOPERATIVELY A FRACTURE OF TAPER AT THE CONNECTION OF TIBIAL PLATEAU TO TIBIAL STEM WAS SEEN. UPDATE: 12/13/2017 MEDICAL RECORDS REVIEWED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, THERE WAS LOOSENING OF THE TIBIAL COMPONENT OF THE NOILES RIGHT-KNEE JOINT TEP WITH SCREW BREAKAGE AT THE TRANSITION FROM SLEEVE TO STEM. THE PATIENT THEN HAD INCREASED INSTABILITY AND FALLS. RADIOGRAPHS ARE REPORTED TO SHOW THE TIBIAL COMPONENT DISCONNECTED. DURING THIS REVISION, THE SURGEON NOTED A DISCOLORED SYNOVIA IN THE MANNER OF METALLOSIS AND AN OLD HEMATOMA. THE MEDICAL NOTES REPORTED THAT THE PATIENT WAS IMPLANTED WITH A NOILES KNEE PROSTHESIS ON (B)(6) 2011 DUE TO AN INFECTION OF PREVIOUS IMPLANT. CURRENTLY, IT IS NOT KNOWN IF THOSE WERE DEPUY COMPONENTS

  Patient problems: Fall; Foreign Body Reaction

  MAUDE report 7116616 ↗