ATTUNE 1506-00-009Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10603295042433), received between Oct 6, 2017 and Sep 18, 2025 — classified as 48 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (37 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 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION OF FEMORAL AND TIBIAL ATTUNE COMPONENTS DUE TO TIBIAL LOOSENING. PATIENT WITH HIGH BMI 47, ORIGINALLY IMPLANTED AROUND 2016 CAME BACK IN 2020 FOR A POLY SWAP. TIBIA IS NOW LOOSE AT CEMENT TO IMPLANT INTERFACE AND NEEDED REVISED. CEMENT FROM COMPETITOR BRAND WAS USED. PATIENT WAS REVISED DUE TO TIBIAL LOOSENING AT CEMENT TO IMPLANT INTERFACE, WITH COMPETITOR CEMENT. NO ADDITIONAL INFORMATION AVAILABLE. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE. (B)(4) AND (B)(4) ARE RELATED. (B)(4) WAS CREATED TO CAPTURE EVENT 2025. (B)(4) WAS CREATED TO CAPTURE EVENT 2020.

  Patient problems: Insufficient Information

  MAUDE report 23088576 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT. THE PATIENT WAS HAVING PAIN. THE TIBIA WAS REVISED BUT THE FEMUR WAS KEPT. THERE WAS NO SURGICAL DELAY. WE ARE UNSURE OF THE ORIGINAL IMPLANT DATE.

  Patient problems: Pain

  MAUDE report 20567139 ↗
• InjuryJul 15, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: 1. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? ALL IMPLANTS REMOVE WHICH TOOK 4 HOURS. 2. WHAT IS THE AFFECTED SIDE? RIGHT. 3. IT WAS INDICATED THAT THERE WAS LOOSENING. ON WHAT INTERFACE DID THE LOOSENING OCCURRED? TIBIA.

  Patient problems: Unspecified Infection

  MAUDE report 19743082 ↗
• InjuryAug 12, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT REVISED DUE TO LOOSE TIBIA. THERE WAS LOOSENING WITH INTERFACE OF CEMENT TO IMPLANT AND NO SURGICAL DELAY WAS THERE. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15216329 ↗
• InjuryJul 25, 2022Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  SUNKEN AND LOOSE ATTUNE TIBIA PLATFORM WHILE KNEE REVISION. LOOSENING INTERFACE BETWEEN CEMENT AND IMPLANT; RIGHT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 15093016 ↗
• InjuryMay 17, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(4) MEDICAL RECORDS AD 26 APR 2022 WERE REVIEWED BY CLINICIAN. ON (B)(6) 2014, THE PATIENT HAD A LEFT KNEE ARTHROPLASTY TO ADDRESS DEGENERATIVE JOINT DISEASE. DEPUY PRODUCTS WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2021, THE PATIENT HAD A LEFT KNEE REVISION TO ADDRESS LOOSE TOTAL KNEE ARTHROPLASTY. DURING THE PROCEDURE THE SURGEON REPORTED FINDING LOOSE FEMORAL COMPONENT WITH SIGNIFICANT LATERAL FEMORAL CONDYLAR BONE LOSS AS WELL AS GROSSLY LOOSE TIBIAL COMPONENT. THERE WAS FIBRINOUS TISSUE WITH SIGNIFICANT BONE LOSS AROUND THE FEMORAL COMPONENT. THE TIBIAL TRAY WAS NOTED TO BE GROSSLY LOOSE AT THE CEMENT/IMPLANT INTERFACE. THE INSERT WAS REMOVED WITHOUT ALLEGATION OF DEFICIENCY. DEPUY COMPONENTS WERE IMPLANTED ALONG WITH COMPETITOR CEMENT X2. DOI: (B)(6) 2014; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 14415047 ↗
• InjuryMar 28, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO KNEE PAIN AND LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. DEPUY SMARTSET MEDIUM VISCOSITY BONE CEMENT WOULD HAVE BEEN USED IN THE PRIMARY PROCEDURE, SINCE THE HOSPITAL ONLY STOCKS SMARTSET CEMENTS. THE PRODUCT CODES AND THE LOT NUMBERS FOR THE CEMENT USED ARE NOT AVAILABLE, SINCE THE HOSPITAL ORDERS THEIR CEMENT DIRECTLY FROM DEPUY SYNTHES. ALL OF THE PATIENT'S PRIMARY COMPONENTS, WITH THE EXCEPTION OF THE ATTUNE MEDIALIZED PATELLA IMPLANT, WERE REMOVED AND REPLACED BY ATTUNE REVISION COMPONENTS. SURGEON BELIEVES THERE WAS A FLAW IN THE DESIGN OF THE UNDERSIDE OF THE ORIGINAL ATTUNE TIBIAL TRAYS, SINCE HE HAS HAD TO REVISE MORE THAN A HALF DOZEN ATTUNE CEMENTED FB TIBILA TRAYS DUE TO LOOSENING. THE DEBONDING INTERFACE FOR THE MAJORITY, IF NOT ALL OF THEM OF THOSE SURGERIES, WAS THE CEMENT/IMPLANT INTERFACE. DOI: (B)(6) 2015, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 13930360 ↗
• InjuryAug 13, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2015: PATIENT UNDERWENT A RIGHT TKA DUE TO DJD. PATELLA WAS RESURFACED AND DEPUY CEMENT WAS USED. NO COMPLICATIONS NOTED. ON (B)(6) 2019: PATIENT UNDERWENT A RIGHT TKA REVISION DUE TO ASEPTIC LOOSENING AND INSTABILITY. INTRAOPERATIVE FINDINGS INCLUDED - SWELLING/EFFUSION, MEDIAL LAXITY, FIBROUS SCARRING AND ADHESIONS, AND BLOOD TINGED SYNOVIAL FLUID (SYNOVITIS) THAT WAS ENCROACHING ON THE JOINT CAUSING IMPINGEMENT. THERE WAS A FRAGMENTATION OF THE CEMENT ALONG PERIPHERAL MARGINS OF THE FEMORAL COMPONENT. FEMORAL COMPONENT WAS NOTED TO BE WELL FIXED, BUT SLIGHTLY OVERSIZED. THE TIBIAL INSERT SHOWED WEARING AND PITTING ON MEDIAL SIDE. THE PATELLA HAD SOME FLAT SPOT WITH OSTEOLYTIC CHANGES. THE TIBIAL COMPONENT WAS GROSSLY LOOSE WITH SEPARATION OF THE COMPONENT FROM THE CEMENT. MEDIAL TIBIAL BONE LOSS. ALL DEPUY IMPLANTS WERE REMOVED AND REPLACED WITH COMPETITOR IMPLANTS. ON (B)(6) 2020: PATIENT UNDERWENT AN INSERT EXCHANGED DUE TO INFECTION - COMPETITOR PRODUCTS INVOLVED. DOI: (B)(6) 2015. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: Adhesion(s); Joint Laxity; Swelling/ Edema; Synovitis

  MAUDE report 12319653 ↗
• InjuryJun 24, 2021Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  MEDICAL RECORDS FROM (B)(6) 2021, REPORT THAT PATIENT HAD A REVISION OF TIBIAL COMPONENT RIGHT KNEE TO ADDRESS MECHANICAL LOOSENING OF INTERNAL RIGHT KNEE PROSTHETIC JOINT. DEPUY COMPONENTS WERE USED DURING THIS PROCEDURE ALONG WITH COMPETITOR CEMENT. THE INDICATORS FOR SURGERY INCLUDED PAIN. THE FEMORAL AND PATELLA COMPONENTS WERE NOTED TO BE WELL FIXED.

  Patient problems: Insufficient Information; Pain

  MAUDE report 12061319 ↗
• InjuryMay 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD (B)(6) 2021. PRIMARY OPERATIVE NOTES (B)(6) 2017 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS WITH VARUS DEFORMITY. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT WAS UTILIZED X2. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. ON AN UNK DATE THE TIBIAL INSERT WAS REVISED ALONG WITH AN IRRIGATION AND DEBRIDEMENT DUE TO INFECTION AND PATIENT WAS PLACED ON LONG TERM IV ANTIBIOTICS. (PRODUCT INFO FOR NEW INSERT NOT PROVIDED). REVISION OPERATIVE NOTES (B)(6) 2020 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO PAIN, SWELLING AND CHRONIC PERIPROSTHETIC JOINT INFECTION. UPON ENTERING THE JOINT, HYPERTROPHIC SYNOVIUM AND SCAR TISSUE WAS ENCOUNTERED AND REMOVED. THE TIBIAL, FEMORAL AND PATELLA COMPONENTS WERE GROSSLY LOOSE AT THE CEMENT TO BONE INTERFACE. ALL IMPLANTS REMOVED AND ANTIBIOTIC SPACER PLACED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: UNKNOWN (TIBIAL INSERT), DOI: (B)(6) 2017 (FEMORAL, TIBIAL BASE, PATELLA AND CEMENT), DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 11771183 ↗
• InjuryApr 1, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT X 2 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO ADDRESS PAIN, INSTABILITY, DIFFICULTY WALKING, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED A LARGE AMOUNT OF SCAR TISSUE, SOME OF WHICH WAS GRAY. THE PATELLAR AND FEMORAL COMPONENTS WERE WELL-FIXED AND RETAINED. THE TIBIAL TRAY AND TIBIAL INSERT WERE REVISED WITH DEPUY PRODUCTS AND DEPUY CEMENT X 2. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2016. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 11604092 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT KNEE REVISED FOR PAIN.

  Patient problems: Pain

  MAUDE report 11124428 ↗
• InjuryAug 19, 2020Malposition of Device; Malposition of Device

  THE PATIENT WAS EXPERIENCING EXCESSIVE EXTERNAL ROTATION OF FOOT WHEN WALKING THAT LED TO THE REVISION SURGERY. THE AFFECTED SIDE WAS THE RIGHT SIDE.

  Patient problems: Ambulation or Postural Difficulties; No Code Available

  MAUDE report 10426181 ↗
• InjuryJun 30, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED A PRIMARY LEFT ATTUNE AND LATERAL RETINACULAR RELEASE TO TREAT PAIN SECONDARY TO DEGENERATIVE JOINT DISEASE. 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 ADHESIONS SECONDARY TO ASEPTIC LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE TIBIAL TRAY WAS LOOSE ON THE LATERAL SIDE OF AN UNKNOWN INTERFACE. THE SURGEON DEBRIDED EXTENSIVE ADHESIONS AND PERFORMED A COMPLETE SYNOVECTOMY. THE FEMORAL COMPONENT AND PATELLA WERE WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED INSERT. THE PATIENT WAS REVISED WITH DEPUY COMPONENTS UTILIZING DEPUY CEMENT X 1. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014; DOR: (B)(6) 2015; LEFT KNEE.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 10214212 ↗
• InjuryMay 11, 2020Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  PATIENT RECEIVED RIGHT PRIMARY ATTUNE TKA TO TREAT OSTEOARTHRITIS WITH A MILD VARUS DEFORMITY AND SIGNIFICANT MEDIAL COMPARTMENT WEAR. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED RIGHT KNEE REVISION TO TREAT PAIN SECONDARY TO LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON CONFIRMED TIBIAL TRAY LOOSENING AT AN UNKNOWN INTERFACE. THE FEMORAL COMPONENT WAS WELL-FIX BUT REVISED. THE SURGEON NOTES THERE WAS A LARGE CYST IN THE POSTERIOR DISTAL PORTION OF THE FEMORAL CONDYLE. THE PATELLA WAS WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED TIBIAL INSERT. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014. DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10044714 ↗
• InjuryMar 23, 2020Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Migration; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Migration

  MEDICAL RECORDS (B)(4) MEDICAL RECORDS AD 30 MAR 2020) REVIEWED. ON (B)(6)2019, PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION TO ADDRESS SEVERE PAIN, ASEPTIC TIBIAL BASE PLATE IMPLANT LOOSENING AND TIBIAL SUBSIDENCE. FINDINGS REPORTED DEBONDING OF THE CEMENT FROM THE TIBIAL BASEPLATE IMPLANT. IT REQUIRED NO INSTRUMENTS TO REMOVE. THE FEMUR WAS WELL-FIXED, BUT REVISED. THE PATELLA WAS WELL-FIXED, TRACKED WELL, AND WAS NOT WORN. THE PATELLA WAS RETAINED. THERE WAS NO WEAR OF THE TIBIAL INSERT EITHER, BUT IT ALSO WAS REVISED.

  Patient problems: No Code Available; Pain

  MAUDE report 9865049 ↗
• InjuryMar 9, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING. DEPUY CEMENT UTILIZED AT PRIMARY X2. DATE OF IMPLANT: (B)(6) 2015; DATE OF REVISION: (B)(6) 2020; (RIGHT KNEE). TIBIAL, FEMORAL AND INSERT REVISED.

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9808274 ↗
• InjuryJan 27, 2020Loss of or Failure to Bond; Malposition of Device; Unintended Movement; Loss of or Failure to Bond; Malposition of Device; Unintended Movement

  PATIENT WAS REVISED TO ADDRESS PAIN, TIBIAL TRAY MIGRATION, MALPOSITIONING AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT MANUFACTURER WAS USED DURING THE PRIMARY OPERATION. THE PATELLA COMPONENT WAS NOT REVISED. ON (B)(6) 2016, THE UNDERWENT A RIGHT KNEE TOTAL KNEE ARTHROPLASTY WITH THE IMPLANTATION OF DEPUY ATTUNE KNEE. DOI: (B)(6) 2016; DOR: (B)(6) 2016 RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9632621 ↗
• InjuryJan 9, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED AD 09 DEC 2019. ON (B)(6) 2017, THE PATIENT UNDERWENT TOTAL RIGHT 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 SMARTSET BONE CEMENT X 2. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, SWELLING, AND PAIN. THE SURGEON REPORTED THE TIBIAL COMPONENT WAS LOOSE IN ITS MANTLE. HE NOTED THE FEMORAL COMPONENT WAS NOT LOOSE. THE SURGEON INDICATED THE PATELLA HAD NO EVIDENCE OF WEAR NOR LOOSENING AND WAS RETAINED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND DEPUY BONE CEMENT. THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2017, DOR: (B)(6) 2019 (RT KNEE).

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9570207 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO POSTTRAUMATIC ARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND COMPETITOR CEMENT. DOI: (B)(6) 2016. DOR: NO REVISION, (RT KNEE).

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

  MAUDE report 9547731 ↗
• InjuryDec 11, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  LEFT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, AND PAIN. THE SURGEON REPORTED THE TIBIAL COMPONENT WAS LOOSE FROM THE CEMENT MANTLE AND EASILY REMOVED WITH PUNCH AND MALLET. HE NOTED A FEMORAL COMPONENT WAS REMOVED WITH MINIMAL BONE LOSS. DOI: (B)(6) 2016; DOR: (B)(6) 2018; (LT KNEE).

  Patient problems: Pain

  MAUDE report 9453268 ↗
• InjuryNov 27, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT UNDERWENT A SECOND RIGHT KNEE REVISION DUE TO PAIN, INSTABILITY, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE PATELLA COMPONENT WAS NOT REVISED. DEPUY CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2014 TIBIAL INSERT, TIBIAL TRAY, FEMORAL COMPONENT, AND DEPUY CEMENT; DOI: (B)(6) 2018 PATELLA COMPONENT; DOR: (B)(6) 2018. RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9384393 ↗
• InjuryNov 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, 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 DEPUY KNEE SYSTEM AND COMPETITOR BONE CEMENT. ON (B)(6) 2018, THE PATIENT UNDERWENT A STAGE 1 REVISION OF THE LEFT KNEE, WITH A TEMPORARY KNEE SPACER DUE TO INFECTION, NICKEL ALLERGY, AND INSTABILITY. THE SURGEON NOTED THE PATIENT WENT THROUGH PICC LINE ANTIBIOTICS. THE PATIENT WAS IMPLANTED WITH DEPUY FEMORAL COMPONENT WITH ALL POLYETHYLENE TIBIAL COMPONENT AND ANTIBIOTIC CEMENT. THE SURGEON NOTED THE PATIENT WENT THROUGH PICC LINE ANTIBIOTICS. DOI: (B)(6) 2016. DOR: (B)(6) 2018 (LT KNEE).

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Unspecified Infection

  MAUDE report 9356112 ↗
• InjuryNov 20, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2014, 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 SMARTSET BONE CEMENT X 2. ON (B)(6) 2018, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, INSTABILITY AND PAIN. THE SURGEON REPORTED THE PATIENT WAS GROSSLY UNSTABLE LATERALLY. HE REPORTED THE TIBIAL COMPONENT WAS LOOSE NEEDING ONE STRIKE OF THE MALLET WHICH RESULTED THE COMPONENT TO DE-BOND 100 PERCENT FROM THE UNDERLYING CEMENT. HE NOTED A WELL-FIXED FEMORAL COMPONENT. THE SURGEON REPORTED THE PATELLA HAD SOME WEAR AND SO WAS REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2014 . DOR: (B)(6) 2018. (RT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9348072 ↗
• InjuryNov 13, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING OF BOTH THE TIBIAL TRAY AND FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED SYNOVITIS AND ADHESIONS WITHIN THE KNEE. THE PATELLA COMPONENT WAS NOT REVISED. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2015; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9317360 ↗