ATTUNE 1506-10-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295042563), received between Aug 10, 2017 and Mar 14, 2023 — classified as 19 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (12 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 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. THE PATIENT HAD BEEN IN PAIN FOR A FEW MONTHS. DOI: (B)(6) 2017. DOR: (B)(6) 2023. LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16541857 ↗
• InjuryJul 5, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED A LEFT PRIMARY ATTUNE TO TREAT DJD. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT PAIN, SWELLING, AND WALKING DIFFICULTY SECONDARY TO SUSPECTED TIBIAL TRAY LOOSENING. UPON ENTERING THE JOINT, THE SURGEON EVACUATED A MILD EFFUSION AND PATHOLOGY CONFIRMED NO INFECTION. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED TO ACCOMMODATE THE REVISION KNEE. THE PATELLA WAS WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATIENT RECEIVED A COMPETITOR CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2017. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 14914591 ↗
• InjuryMar 17, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. THE PATIENT PRESENTED WITH TYPICAL SYMPTOMS SYMPTOMS ASSOCIATED WITH A LOOSE TIBIAL COMPONENT. INTRA-OPERATIVELY, THE TIBIAL COMPONENT WAS DEEMED TO BE LOOSE. MINIMAL EFFORT WAS REQUIRED TO REMOVE THE COMPONENT. NO CEMENT WAS FIXED TO THE EXPLANTED TIBIAL COMPONENT. TIBIA WAS REVISED USING A STEMMED AND SLEEVED TIBIAL COMPONENT. THE ORIGINAL COMPONENT WAS A FIRST GENERATION ATTUNE. COMPETITOR BONE CEMENT WAS USED. DOI: (B)(6) 2016. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 13802636 ↗
• InjuryNov 1, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED. ON (B)(6) 2015, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS LEFT KNEE ARTHRITIS, POST PREVIOUS MENISCUS REPAIR. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA, AND COMPETITOR CEMENT X2 WERE IMPLANTED DURING THIS PROCEDURE. (STICKER SHEET PAGE 4 OF 9). ON (B)(6) 2021, THE PATIENT HAD A LEFT TOTAL KNEE REVISION TO ADDRESS TIBIAL TRAY LOOSENING. DURING THE PROCEDURE, THE SURGEON OBSERVED THAT THE TIBIAL TRAY HAD DEBONDED FROM THE CEMENT MANTLE AND ARTHROFIBROSIS. THE FEMORAL COMPONENT WAS NOTED TO BE WELL-FIXED. THE INSERT WAS REVISED WITH NO ALLEGATION OF DEFICIENCY.

  Patient problems: Adhesion(s); Pain

  MAUDE report 12728996 ↗
• InjuryNov 18, 2020Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  THE PATIENT WAS REVISED TO ADDRESS SUBSIDENCE AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURE WAS UNKNOWN. DOI: (B)(6) 2018, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10860654 ↗
• InjuryOct 2, 2020Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC EFFUSION, REDUCED RANGE OF MOTION (+15 TO +80 DEGREES), PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. SHE HAD A PREVIOUS POLY REVISION BY THE SURGEON ON (B)(6) 2016. SHE HAD A FLEXION-EXTENSION GAP MISMATCH OF 4MM. THE ATTUNE TIBIAL TRAY CAME OUT WITH RELATIVE EASE ALTHOUGH SALES REP WAS SURE THAT THE SURGEON ALSO CHECKED THE FIXATION OF THE TIBIAL TRAY WHEN HE DID THE FIRST REVISION WITH POLY EXCHANGE BACK IN 2016. THE TRAY CAME OUT WITH EASE AND NO CEMENT ON THE BACK OF THE TRAY. DOI: (B)(6) 2015; (B)(6) 2016 ( TIBIAL INSERT ), DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Edema; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 10621457 ↗
• InjuryAug 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE KNEE AND PAIN. DOI: (B)(6) 2018 DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10414338 ↗
• InjuryJul 28, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED A LEFT PRIMARY ATTUNE TO TREAT PAIN SECONDARY TO DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 1 WAS UTILIZED. THE SURGEON NOTES THE PATIENT HAD GROSS NATURAL LAXITY TO VARUS AND VALGUS STRESSING. THE SURGEON ELECTED TO PLACE THE COMPONENTS TO MATCH THE PATIENT¿S NATURAL LIGAMENTOUS LAXITY. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A LEFT TKA REVISION TO TREAT PAIN SECONDARY TO LOOSENING. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE. THE PATELLA WAS WELL-FIXED AND RETAINED. THE FEMORAL COMPONENT WAS WELL-FIXED AND REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATIENT WAS IMPLANTED WITH COMPETITOR PRODUCTS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2018. DOI: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10334013 ↗
• InjuryJun 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A LAX TOTAL KNEE. THE SURGEON PLANNED TO PUT IN A THICKER INSERT. THE FEMUR AND PATELLA ARE WELL FIXED AND RETAINED. THE TIBIAL TRAY CAME OUT AFTER MULTIPLE HARD HITS. THE TRAY APPEARED TO BE SOLID EVEN THOUGH THERE WAS NO CEMENT ON ITS BACKSIDE. IT WAS ALSO REPORTED THAT DURING REASSEMBLY OF THE INSTRUMENTS, IT WAS DISCOVERED THAT ONE RETAINING SPRING WAS MISSING ON THE SPACER BLOCK, AND ONE WAS SPRUNG ON THE TIBIAL INSERT TRIAL. THE MISSING SPRING WAS NOT PRESENT AND IT IS UNKNOWN WHERE IT IS. IT COULD HAVE BEEN LEFT IN THE PATIENT. THIS WAS CAPTURED IN (B)(4). DOI: (B)(6) 2016; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10212504 ↗
• InjuryDec 17, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2015, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND UNKNOWN BONE CEMENT. ON (B)(6) 2018, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, PATELLAR INSTABILITY, AND PAIN. THE SURGEON REPORTED THE TIBIAL COMPONENT WAS COMPLETELY DE-BONDED FROM THE CEMENT MANTLE AND WAS EXTRACTED WITH ABSOLUTELY NO WORK. HE NOTED THE FEMORAL COMPONENT WAS WELL-FIXED BUT EASILY EXTRACTED WITH NO SIGNIFICANT BONE LOSS. THE SURGEON INDICATED THE PATELLA WAS FOUND TO BE WELL-FIXED, TRACKED WELL AND NO OVERT EXPLANATION FOR THE PATIENTS¿ SUBJECTIVE SENSE OF PATELLAR INSTABILITY. HE NOTED A BAND OF FIBROUS TISSUE THAT OVERHUNG THE PATELLAR COMPONENT WHICH WAS DEBRIDED. WAS RETAINED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2015 DOR: (B)(6) 2018 (LT KNEE). PRIMARY PRODUCT INFORMATION CAN BE FOUND ON PAGE 9/19 AND 10/19 OF THE ATTACHED MEDICAL RECORDS. PLEASE ADD 2 UNKNOWN CEMENT PRODUCTS WERE USED DURING PRIMARY OPERATION, AS N

  Patient problems: Adhesion(s); No Code Available; Pain

  MAUDE report 9484166 ↗
• InjuryDec 16, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  RECORDS INDICATE PATIENT RECEIVED BILATERAL ATTUNE TKAS. NO ALLEGATIONS PROVIDED OF PATIENT INJURY OR PRODUCT FAILURE, NOR REPORT OF REVISION. ON (B)(6) 2015, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND UNKNOWN BONE CEMENT. ON (B)(6) 2018, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, PATELLAR INSTABILITY, AND PAIN. THE SURGEON REPORTED THE TIBIAL COMPONENT WAS COMPLETELY DE-BONDED FROM THE CEMENT MANTLE AND WAS EXTRACTED WITH ABSOLUTELY NO WORK. HE NOTED THE FEMORAL COMPONENT WAS WELL-FIXED BUT EASILY EXTRACTED WITH NO SIGNIFICANT BONE LOSS. THE SURGEON INDICATED THE PATELLA WAS FOUND TO BE WELL-FIXED, TRACKED WELL AND NO OVERT EXPLANATION FOR THE PATIENTS¿ SUBJECTIVE SENSE OF PATELLAR INSTABILITY. HE NOTED A BAND OF FIBROUS TISSUE THAT OVERHUNG THE PATELLAR COMPONENT WHICH WAS DEBRIDED. WAS RETAINED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2015. DOR: (B)(6) 2018 (LT KNEE). PRIMARY PRODUCT INFORMATION CA

  Patient problems: No Code Available; Pain

  MAUDE report 9474519 ↗
• InjurySep 13, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 22 AUGUST 2019 FOR MDR REPORTABILITY. ON (B)(6) 2015, THE PATIENT UNDERWENT LEFT KNEE ARTHROPLASTY DUE TO OSTEOARTHROSIS, PAIN, AND CATCHING. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS AND PATIENT WAS TRANSFERRED TO RECOVERY IN GOOD CONDITION. ALL ATTUNE COMPONENTS, AND TWO SMARTSET CEMENTS WERE UTILIZED IN THE PROCEDURE. ON (B)(6) 2017, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT AND PAIN. THE SURGEON NOTED THE TIBIAL COMPONENT WAS GROSSLY LOOSE, HE DID NOT SPECIFY THE INTERFACE. HE REPORTED THE FEMORAL COMPONENT AND THE TIBIA WERE WELL FIXED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. DEPUY SMARTSET CEMENT X 2 WERE USED IN THE PROCEDURE. ALL OTHER COMPETITOR COMPONENTS WERE UTILIZED. DOI: (B)(6) 2015. DOR: (B)(6) 2017. (LT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9047917 ↗
• InjuryJun 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION: ONGOING ANTERIOR KNEE PAIN. UPDATE- UNDERWENT RADIOFREQUENCY ABLATION OF GENICULATE NERVES ON (B)(6) 2019

  Patient problems: No Code Available; Pain; Swelling

  MAUDE report 8726449 ↗
• InjuryJun 11, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS OPERATED ON ABOUT A YEAR AGO AND RECENTLY UNDERWENT A REPEAT OPERATION DUE TO SUSPICION OF INFECTION. WHEN THE KNEE OPENED TOWARDS THE FIRST STAGE, THE KNEE DID NOT APPEAR TO BE CONTAMINATED AT ALL, BUT THE TIBIAL SURFACE WAS COMPLETELY LOOSE AND WAS REMOVED WITH THE FINGER WHEN THERE WAS NO CONNECTION BETWEEN THE CEMENT AND THE IMPLANT. AS FOR THE CONNECTION BETWEEN THE CEMENT AND THE BONE IT SEEMS THAT THERE IS AN EXCELLENT CONNECTION. AS A RESULT, IT IS LIKELY THAT THE CAUSE OF THE PATIENT'S PAIN IS NOT THE INFECTION BUT THE WEAKENING OF THE TIBIAL SURFACE.

  Patient problems: No Code Available; Pain

  MAUDE report 8687999 ↗
• InjuryMay 16, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: UNKNOWN; DOR: (B)(6) 2019, RIGHT SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 8617308 ↗
• InjuryFeb 8, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THE PATIENT WAS REVISED ON (B)(6) 2019, TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE IN THE LEFT KNEE. DEPUY CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE PATIENT HAD A REVISION OF NON-DEPUY PRODUCT TO TOTAL ON (B)(6) 2017 WHERE THE DEPUY IMPLANTS WERE IMPLANTED. AT SOME POINT THE PATIENT WAS IN A CAR ACCIDENT AND AN INJURY WAS SUSTAINED THE THAT KNEE. THE INJURY TO THE KNEE CONTINUED SO A REVISION OF TOTAL KNEE WAS REQUIRED. DURING THE REVISION THE TIBIA WAS FOUND TO BE LOOSE. IMPLANT AND CEMENT WERE REMOVED AND ATTUNE REVISION TIBIAL, STEM, AND AUGS WERE IMPLANTED.

  Patient problems: Injury; No Code Available

  MAUDE report 8323278 ↗
• InjuryNov 29, 2018Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available; Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL BASE PLATE COMPONENT AT THE CEMENT TO IMPLANT INTERFACE.

  Patient problems: No Information

  MAUDE report 8116825 ↗
• InjuryFeb 1, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THERE IS NO CEMENT ATTACHED TO THE UNDERSURFACE OF THE TIBIAL TRAY.;EVEN-THOUGH IT WAS WELL FIXED. FEMUR INSPIRE BEING LOOSE HAD CEMENT MANTLE ATTACHED TO IT. CEMENT USED IN THIS CASE WAS PALACOS G. PATIENT WAS OPERATED ON (B)(6) 2017. WAS DOING FINE BUT HAD A PERIPROSTHETIC FRACTURE WHICH HAD TO BE REVISED. SO, MAIN CONCERN WAS PERIPROSTHETIC FRACTURE, DEBONDING WAS OBSERVED WHILE TAKING OUT IMPLANTS. THIS TIBIAL DEBONDING CAN BE INVESTIGATED FOR REASONS AS IT SHOULD HAVE HAD GOOD BONE CEMENT INTERFACE. DOI: (B)(6) 2017; DOR: UNKNOWN; UNKNOWN AFFECTED SIDE.

  Patient problems: Limited Mobility Of The Implanted Joint; No Consequences Or Impact To Patient; Pain

  MAUDE report 7233775 ↗
• InjuryAug 10, 2017Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED.

  Patient problems: No Code Available

  MAUDE report 6786384 ↗