NA 86-7428Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295217909), received between Sep 27, 2018 and Jul 17, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2026Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL TRAY, SLEEVE AND STEM AT THE BONE TO IMPLANT INTERFACE. THE PATIENT PRESENTS WITH PAIN AROUND THE TIBIAL IMPLANT. LUCENCIES ARE PRESENT ON X-RAY AND THE PATIENT IS SCHEDULED FOR A TIBIAL REVISION. OPERATIVELY, THE DISTAL FEMORAL COMPONENT IS REMOVED TO GAIN EXPOSURE. THE TIBIAL COMPONENT WAS WELL FIXED AT THE CEMENT INTERFACE. ONCE THEY WERE REMOVED, LITTLE INGROWTH WAS PRESENT ON THE SLEEVE. PREPARATION FOR NEW TIBIAL COMPONENTS IS PERFORMED AND TRIALING WAS PERFORMED SHOWING GOOD ROM AND STABILITY. NEW COMPONENTS ARE PLACED. NO DELAY NOR PATIENT HARM IS NOTED. SIGNIFICANT BONE LOSS WAS NOTED IN THE PROXIMAL TIBIA AND COULD HAVE BEEN THE REASON FOR LATE LOOSENING, AS THE TIBIAL SLEEVE WAS ONLY AVAILABLE WITH A PARTIALLY POROUS SLEEVE. THIS WOULD HAVE HAD LITTLE CONTACT WITH HOST BONE DURING THE PREVIOUS SURGERY. THE ATTUNE REVISION NOW HAS A FULLY POROUS OPTION WHICH WAS UTILIZED DURING THIS PROCEDURE AND PROVIDED MORE CONTACT AREA. DOI: (B)(6), 2023 DOR: (B)(6), 2026 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Notching; Inadequate Osseointegration; Pain

  MAUDE report 25861066 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT HAD REVISION SIGMA COMPONENTS CURRENTLY IMPLANTED BUT THE TIBIAL COMPONENT HAD FALLEN INTO VARUS AND THE TIBIAL STEM WAS PROTRUDING OUT OF THE LATERAL CORTEX OF THE TIBIA. THIS PATIENT ALSO HAD STABILITY ISSUES SO SURGEON REMOVED BOTH THE TIBIAL AND FEMORAL COMPONENTS AND REPLACED THEM WITH AN ATTUNE REVISION TIBIAL TRAY, STEM, AND SLEEVE. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17446613 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION TKR AS PART OF A SECOND STAGE DUE TO INFECTION. PATIENT HAS PRESENTED TO DR DAVID LIU AND UNDERGONE A POLY EXCHANGE AND WASHOUT. AT THIS STAGE, ON OPENING THE KNEE, THE KNEE WAS OBVIOUSLY PUSSY AND INFECTED. THE KNEE WAS WASHED OUT AND THE POLY BEARING EXCHANGED. SAMPLES TAKEN AT THIS STAGE ARE POSITIVE FOR BACTERIA (SENSITIVE STRAIN). A DECISION WAS MADE TO GO BACK INTO THE KNEE AND REMOVE ALL COMPONENTS AS PART OF A TWO STAGE PROCEDURE. ON OPENING THE KNEE IT APPEARED RELATIVELY ANGRY BUT NOT OVERTLY PUSSY. THE COMPONENTS WERE REMOVED, THE TISSUE DEBRIDED AND A TEMPORARY "KIWI" SPACER IMPLANTED (ATTUNE PS FEMUR AND AN ATTUNE PS RP INSERT) AS PART OF THE TEMPORARY SPACER. THESE WILL BE REMOVED IN DUE COURSE AND EXCHANGED FOR A REVISION SYSTEM.

  Patient problems: Unspecified Infection

  MAUDE report 15973953 ↗
• InjuryMay 10, 2022Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO LOOSENING OF FEMORAL COMPONENT AT NON- CEMENTED INTERFACE. NO SURGICAL DELAY. DOI- (B)(6) 2022; DOR- (B)(6) 2022; AFFECTED SIDE- LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14345958 ↗
• 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 12862926 ↗
• 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 12295571 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THE FOLLOWING: 1. WAS THE CEMENT MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE QUANTITY, PRODUCT AND LOT NUMBERS. NO, PALACOS CEMENT WAS USED IN THE PREVIOUS OPERATION. 2. IT WAS MENTIONED IN THE EVENT DESCRIPTION THAT THE PATIENT HAD A REVISION OF HER RIGHT KNEE BY MR (B)(6) AT (B)(6) HOSPITAL ON THE (B)(6) 2019. DID THIS REVISION INVOLVE EXPLANTATION OF DEPUY PRODUCTS? IF SO, WAS THIS REVISION REPORTED? (IF THIS REVISION HAS BEEN PREVIOUSLY REPORTED PLEASE PROVIDE THE PC # IF KNOWN). NO, IT WAS A COMPETITOR KNEE REPLACEMENT THAT WAS REVISED. 3. IT WAS INDICATED THAT LOOSENING WAS DUE TO INFECTION. CAN YOU PLEASE ADVISE THE LOOSENING COMPONENT/S AND LOOSENING INTERFACE? THE FEMORAL AND TIBIAL COMPONENTS WERE LOOSE AT THE BONE CEMENT INTERFACE AROUND THE DISTAL FEMUR AND PROXIMAL TIBIA, THERE WAS ALSO SOME LOOSENING AROUND THE FEMORAL SLEEVE. 4. WAS SURGERY TIME EXTENDED? IF YES, WHAT WAS THE DURATION OF THE DELAY? AS THIS WAS A REVISION PROCEDURE THERE WAS NO EXTENSION TO THE SURGICAL TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 12235720 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT RECEIVED A SECOND LEFT KNEE REVISION TO ADDRESS PAIN, INSTABILITY, REMOVAL OF FIBROUS TISSUE, AND PATELLAR TENDON REPAIR. ALL PRODUCTS WERE REVISED WITH THE EXCEPTION OF THE PATELLAR COMPONENT, WHICH WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR FEMORAL COMPONENT AND UNIVERSAL SLEEVE, DEPUY TIBIAL TRAY, STEM, AND INSERT, AND DEPUY CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2017 (PATELLA), DOI: (B)(6) 2018 (COMPETITOR CEMENT, INSERT, TIBIA AND FEMUR - CAPTURED IN (B)(4)), DOR2: (B)(6) 2019, LEFT KNEE.

  Patient problems: Adhesion(s); Joint Laxity; Pain

  MAUDE report 12010185 ↗
• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT PRIMARY UNICOMPARTMENTAL KNEE REPLACEMENT ON (B)(6) 2018. PATIENT PRESENTED WITH A FRACTURE OF THE TIBIAL PLATEAU - AT THIS POINT THE UNICOMPARTMENTAL KNEE WAS REVISED TO A PFC TC3 RP. PATIENT HAS REPORTED ONGOING PAIN AND DISCOMFORT FROM TIME OF REVISION PROCEDURE. BONE SCANS INDICATE INCREASED UPTAKE AROUND THE TIP OF THE TIBIAL STEM AND AROUND THE RESURFACED PATELLA. A DECISION WAS MADE TO REVISE SOME/ ALL OF THE TC3. ON OPENING THE KNEE, ALL THE COMPONENTS WERE FOUND TO BE WELL FIXED. EXTENSIVE SCARRING/ SCAR TISSUE WAS FOUND AROUND THE INFERIOR POLE OF THE PATELLA COMPONENT - THIS WAS EXCISED. THE TIBIAL TRAY AND STEM WERE REMOVED LEAVING THE TIBIAL SLEEVE IN SITU. THE SLEEVE WAS AGAIN CHECKED TO ENSURE IT WAS WELL FIXED. AN ALTERNATIVE TRAY WAS IMPLANTED INTO THE FIXED TIBIAL SLEEVE, BUT THIS TIME WITHOUT A STEM. THE VIEW BEING THAT THE SLEEVE IS WELL FIXED AND THE LOAD WOULD TRANSFER THROUGH THE SLEEVE - THE STEM WOULD THEN NOT BE REQUIRED AND WOULD ALSO PREVENT LOADING AROUND THE TIP OF THE STEM, WHICH HAD POTENTIALLY CAUSED THE PAIN. A NEW BEARING WAS IMPLANTED AND THE KNEE CLOSED.

  Patient problems: Adhesion(s); Discomfort; Pain

  MAUDE report 11813756 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. DATE OF IMPLANTATION. NOT SURE SORRY. B. LOT NUMBER: UNIVERSAL STEM 115X14MM FLUTED (867428) AND LPS XX-SM HINGE PIN. REFER IMAGE UPLOADED. C. PLEASE CONFIRM IF THE CEMENT WAS MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE QUANTITY, PART AND LOT NUMBERS OF THE CEMENT. NO STYKER.

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

  MAUDE report 11796219 ↗
• InjurySep 16, 2020Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. PATIENT HAS COMPLAINED OVER A LONG PERIOD OF TIME AT THE END OF STEM, PAIN IN HER TIBIA. DOI: (B)(6) 2018. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10540605 ↗
• InjurySep 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL NOTIFICATION RECEIVED FOR RIGHT KNEE REVISION TO ADDRESS IMPLANT LOOSENING AND IMPLANT FRACTURE. DATE OF IMPLANTATION: UNK/UNK/1992, DATE OF REVISION #1: (B)(6) 2016 (INSERT, PATELLA), DATE OF REVISION #2: (B)(6) 2016 (FEMUR, TIBIAL BASE PLATE, INSERT), DATE OF REVISION #3: (B)(6) 2020, (RIGHT KNEE). TREATMENT: REVISION OF FEMUR CONSTRUCT, HINGED TIBIAL INSERT, AND TIBIA CONSTRUCT IMPLANTS.

  Patient problems: No Code Available; Pain

  MAUDE report 10487946 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FEMUR WAS REVISED TO A FULLY COATED STEM AND DISTAL FEMUR REPLACEMENT TO GAIN STABILITY. DOI: (B)(6) 2019; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10311442 ↗
• InjuryJun 25, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE SLEEVE AND STEM AT THE BONE TO IMPLANT INTERFACE. THE MBT REVISION TIBIA AND STEM WERE KEPT. IMPLANT PART NUMBERS ARE UNKNOWN. THE FEMORAL SIDE WAS NOT GROSSLY LOOSE. NO SURGICAL DELAY NOTED. DOI: (B)(6) 2017, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10196521 ↗
• InjuryMay 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TREATED WITH A KNEE REPLACEMENT ON THE (B)(6) 2019. PATIENT WAS ADMITTED TO HOSPITAL DUE TO AN INFLAMMATION IN THE KNEE. REVISION SURGERY PLANNED FOR THE (B)(6) 2020. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Inflammation; No Code Available

  MAUDE report 10048012 ↗
• InjuryFeb 14, 2020Material Twisted/Bent; Material Twisted/Bent

  UPDATE ADDITIONAL INFORMATION RECEIVED 21 FEB 2020. IT WAS REPORTED THAT THE REASON FOR REVISION WAS DUE TO THE TIBIAL TRAY THAT THE SPLINE ON THE COMPONENT BENT ON.

  Patient problems: No Code Available

  MAUDE report 9711421 ↗
• InjuryDec 18, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ON OPENING THE KNEE THE TIBIAL COMPONENTS WERE SOMEWHAT LOOSE AND PATIENT WAS EXPERIENCING PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 9488944 ↗
• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2019. DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9072652 ↗
• InjuryFeb 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED ON (B)(6) 2019 TO ADDRESS PAIN AND LOOSENING OF THE MBT REVISION COMPONENTS AT THE BONE TO CEMENT AND BONE TO IMPLANT INTERFACE IN THE RIGHT KNEE. DEPUY CEMENT WAS USED. ALL COMPONENTS OF TC3 MBT REVISION WERE REMOVED. THE ORIGINAL IMPLANT DATE WAS (B)(6) 2016.

  Patient problems: No Code Available; Pain

  MAUDE report 8353398 ↗
• InjuryFeb 15, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMUR AND STEM AT THE BONE TO IMPLANT INTERFACE PER PRE-OP TESTING. THE SLEEVE WAS EXPLANTED THAT DID INDICATE INGROWTH,IT WAS REVISED TO A LONGER STEM AND A BIGGER SLEEVE. DOI: (B)(6) 2017; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8343002 ↗
• InjuryOct 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF PFC TC3 COMPONENTS DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7934785 ↗
• InjurySep 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FEMORAL COMPONENT OF THE PATIENT WAS REVISED DUE TO PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 7915412 ↗