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ATTUNE 1504-10-125Recalls & reported problems

Depuy (Ireland) · ATTUNE KNEE SYSTEM FEMORAL POSTERIOR STABILIZED NARROW SIZE 5N LEFT CEMENTED · Class 3 · Implant

All models of ATTUNE (1475)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This DePuy Attune knee implant has 86 adverse event reports: 84 injuries and 2 malfunctions, with no deaths. The reports mostly describe pain, knee instability, and components loosening where they bond to the cement, and some describe infection requiring revision surgery. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
86
Deaths reported
0
Injuries reported
84
Recalls naming it
0

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 10603295041702), received between Feb 20, 2018 and Jun 30, 2026 — classified as 84 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (17 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 2 reportsJul 2025: 1 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem57
  • Loss of or Failure to Bond17
  • Malposition of Device3
  • Noise, Audible3
  • Use of Device Problem3
  • Insufficient Device Problem Information2
  • Loosening of Implant Not Related to Bone-Ingrowth2
  • Migration2

Patient problems

  • Pain46
  • No Code Available42
  • Adhesion(s)11
  • Joint Laxity10
  • Unspecified Infection10
  • Osteolysis7
  • Synovitis7
  • Edema6

Recent adverse event reports

The 25 most recent of 86 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT HAD LIGAMENTOUS INSTABILITY. CEMENT WAS PREPARED IN THE CUSTOMARY WAY ACCORDING TO THE MANUFACTURER'S DIRECTION. MIXED IN A PRISM 2 MIXING GUN AND DELIVERED VIA THE PRISM GUN ITSELF. NO OTHER INFORMATION IS AVAILABLE. COMPONENTS THAT WERE LOOSE: TIBIA LOOSENING INTERFACE: BONE TO CEMENT. CEMENT MANUFACTURER: DEPUY. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

    Patient problems: Joint Laxity

    MAUDE report 25669004 ↗
  • InjuryApr 8, 2026Loss of or Failure to Bond

    IT WAS REPORTED THAT ON (B)(6), 2015 THE PATIENT RECEIVED A LEFT ATTUNE TKA TO TREAT DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PRIMARY PART/LOT INFORMATION IS AVAILABLE ON PP. 1. ON (B)(6) 2022 THE PATIENT RECEIVED A LEFT KNEE ATTUNE TKA TO TREAT PAIN AND A SUBSIDED TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND DEBRIDED SCAR TISSUE, SYNOVITIS, AND EDEMA. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE FEMORAL COMPONENT WAS LOOSENED AT THE CEMENT TO IMPLANT AND CEMENT TO BONE INTERFACE AND REVISED. THERE WAS EXTENSIVE FEMORAL OSTEOLYSIS AND INFLAMMATION. THE TIBIAL TRAY WAS LOOSENED AT AN UNKNOWN INTERFACE AND HAD MIGRATED AND WAS REVISED. THE PATELLA WAS WELL-FIXED AND RETAINED. THE PATIENT RECEIVED AN ATTUNE REVISION CONSTRUCT WITH UNKNOWN CEMENT. DURING THE REVISION, THE FEMORAL AUGMENT DID NOT SEAT ON THE FEMORAL COMPONENT PROPERLY, WHICH CAUSED A FEMORAL CRACK WHEN THE SURGEON ATTEMPTED TO IMPLANT THE FEMORAL COMPONENT. THE AUGMENT WAS REPOSITIONED AND THE NEW FEMORAL COMPONENT SEATED APPROPRIATELY. THE CRACK WAS TREATED WITH A CERCLAGE C

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

    MAUDE report 24818280 ↗
  • InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT HAD A COMPLEX PRIMARY TOTAL KNEE REPLACEMENT ON (B)(6) 2025 USING A PRIMARY ATTUNE PS FEMUR, ATTUNE PS ROTATING PLATFORM INSERT, ATTUNE REVISION ROTATING PLATFORM TIBIAL TRAY WITH ATTUNE REVISION TIBIAL SLEEVE AND ATTUNE REVISION PRESSFIT STEM. THE PATIENT HAD A PREVIOUS TIBIAL PLATEAU FRACTURE THAT HAD BEEN REPAIRED USING PLATES AND SCREWS, WHICH HAD SUBSEQUENTLY BEEN REMOVED PRIOR TO THE TOTAL KNEE REPLACEMENT SURGERY. AT THE TIME OF THE TKR SURGERY, NO CONCERNS WERE NOTED. POST-SURGERY, THE PATIENT¿S MEDIAL COLLATERAL LIGAMENT APPEARS TO HAVE FAILED (THIS OCCURRED 2 DAYS POST-OP ON (B)(6) 2025), RESULTING IN THE KNEE BEING IN SEVERE VALGUS AND X-RAY INDICATING THAT THE POLY INSERT WAS NOW ROTATED OUT OF ITS INITIAL POSITION. THE KNEE WAS SUBSEQUENTLY PLACED IN A RANGE OF MOTION BRACE AND FOLLOW-UP X-RAYS SHOWED THE KNEE TO BE IN GOOD ALIGNMENT IN BOTH THE AP AND LATERAL VIEWS. AT THIS STAGE, NO FURTHER ACTION IS PLANNED BUT THE PATIENT WILL BE REVIEWED IN A COUPLE OF WEEKS.

    Patient problems: Joint Laxity; Unspecified Tissue Injury

    MAUDE report 22895454 ↗
  • InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO UNSTABLE KNEE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

    Patient problems: Joint Laxity

    MAUDE report 22494249 ↗
  • InjuryJun 5, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY (TKA) TO ADDRESS SIGNIFICANT ARTHRITIS INVOLVING HER LEFT KNEE. ATTUNE KNEE SIZE 4 TIBIAL BASE PLATE, A SIZE 5 POSTERIOR STABILIZED ATTUNE FEMUR, A SIZE 5 5MM THICK POLYETHYLENE ROTATING PLATFORM TIBIAL INSERT COMPONENT, AND 38MM ALL-POLY PATELLA WERE IMPLANTED. SMART SET GMV GENTAMICIN BONE CEMENT WAS UTILIZED DURING THE PROCEDURE. NO COMPLICATIONS WERE REPORTED. LESS THAN FOUR YEARS AFTER HER INITIAL LEFT KNEE IMPLANT SURGERY, PATIENT'S LEFT KNEE WAS REVISED TO ADDRESS ASEPTIC LOOSENING OF THE FEMUR AND TIBIAL TRAY COMPONENTS. THE PATIENT PRESENTED WITH FLUID ON THE KNEE, AND SYNOVITIS. OPERATIVELY, THERE WAS MINIMAL CEMENT ADHESION TO THE IMPLANTS (ONLY 20% BENEATH FEMUR, AND 40% BENEATH THE TIBIAL TRAY). THE PATELLA IMPLANT WAS RETAINED. ATTUNE REVISION KNEE COMPONENTS WERE IMPLANTED FOR FEMUR AND TIBIAL SIDE COMPONENTS.

    Patient problems: Swelling/ Edema; Synovitis

    MAUDE report 22148455 ↗
  • MalfunctionJun 2, 2025Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material

    IT WAS REPORTED THAT SURGEON REFUSED DUE TO PACKAGING MALFUNCTION. THE OUTER PACKAGING STUCK TO INNER PACKAGING AND RIPPED WHEN IT WAS BEING OPENED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22122635 ↗
  • InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO KNEE INFECTION, SURGEON EXPLANTED COMPONENTS AND REVISING WITH TEMPORARY SPACER. THERE WAS NO LOOSENING. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

    Patient problems: Unspecified Infection

    MAUDE report 19312604 ↗
  • MalfunctionApr 2, 2024Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

    ADDITIONAL INFORMATION STATES THAT THE AFFECTED SITE WAS THE LEFT SIDE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19029340 ↗
  • InjuryFeb 22, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

    IT WAS REPORTED THAT THE KNEE WAS REVISED DUE TO LOOSE FEMUR. .

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18764235 ↗
  • InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT HAD EXPLANT OF IMPLANTS BECAUSE OF INFECTION. 2 STAGE REVISION. DOI: (B)(6), 2022 DOR: (B)(6), 2023 AFFECTED SIDE: LEFT KNEE.

    Patient problems: Unspecified Infection

    MAUDE report 16639363 ↗
  • InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT WAS REVISED DUE TO AN UNKNOWN REASON. DOI: (B)(6) 2021 DOR: (B)(6) 2023 AFFECTED SIDE: LEFT KNEE.

    Patient problems: Unspecified Infection

    MAUDE report 16459650 ↗
  • InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT WAS REVISED DUE TO AN INFECTED KNEE. DOI : (B)(6) 2022. DOR : (B)(6) 2022. AFFECTED SIDE : LEFT KNEE.

    Patient problems: Unspecified Infection

    MAUDE report 15902573 ↗
  • InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE SURGERY WITH THE IMPLANT (UNK) IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT FELL. THAT CAUSED HIM/HER TO BECOME INFECTED. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Fall; Fever; Unspecified Infection

    MAUDE report 15787768 ↗
  • InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO PAIN AND STIFFNESS. DATE OF IMPLANT: (B)(6) 2020. DATE OF REVISION: (B)(6) 2022 (RIGHT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL AND INSERT WERE REMOVED.

    Patient problems: Muscular Rigidity; Pain

    MAUDE report 15537414 ↗
  • InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION COMPLETED DUE TO INFECTION. IMPLANTS WERE REMOVED. SURGEON INJECTED CEMENT WITH ANTIBIOTIC AND INSERTED A CEMENT SPACER MOLD. DOI: (B)(6) 2015, DOR: UNKNOWN, LEFT KNEE.

    Patient problems: Unspecified Infection

    MAUDE report 14850843 ↗
  • InjuryJan 13, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    IT WAS REPORTED THAT LEFT FEMORAL COMPONENT WAS IMPLANTED IN THE RIGHT KNEE. LEFT COMPONENT WAS REVISED TO THE RIGHT SIDE AND IMPLANTED. SURGERY WAS COMPLETED AND THE PATIENT WAS TAKEN TO RECOVERY IN GOOD CONDITION. 1 HOUR SURGICAL DELAY. DOI: (B)(6) 2021; RIGHT KNEE.

    Patient problems: Insufficient Information

    MAUDE report 13251246 ↗
  • InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT RECEIVED A LEFT ATTUNE KNEE TO TREAT DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO ADDRESS PAIN, OSTEOLYSIS, TIBIAL INSERT WEAR, TIBIAL BONE INJURY, TIBIAL TRAY MIGRATION, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED THE REMOVAL OF FIBRINOUS TISSUE AS WELL AS REMOVAL OF MENISCUS OF TISSUE THAT HAD DEVELOPED AROUND THE POLY PATELLA COMPONENT. THE POLY PATELLA COMPONENT WAS INTACT WITH VERY LITTLE WEAR AND WAS RETAINED. THE TIBIAL INSERT, TIBIAL TRAY, AND FEMORAL COMPONENT WERE REVISED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2014, DOR: (B)(6) 2020, LEFT KNEE.

    Patient problems: Adhesion(s); Osteolysis; Pain; Unspecified Tissue Injury

    MAUDE report 13170151 ↗
  • InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT RECEIVED A LEFT ATTUNE KNEE TO TREAT TRICOMPARTMENTAL DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT X 2 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO ADDRESS INSTABILITY, OSTEOLYSIS IN THE LATERAL FEMORAL CONDYLE DISTALLY, PAIN, TIBIAL TRAY MIGRATION, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE TIBIAL TRAY, TIBIAL INSERT, AND FEMORAL COMPONENT WERE REVISED. THE PATELLA COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2015, DOR: (B)(6) 2020, LEFT KNEE.

    Patient problems: Joint Laxity; Osteolysis; Pain

    MAUDE report 13110104 ↗
  • InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT REMOVED INFECT ATTUNE KNEE AND IMPLANTED CEMENT SPACE. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

    Patient problems: Unspecified Infection

    MAUDE report 12847045 ↗
  • InjuryNov 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT WAS REVISED DUE TO INSTABILITY, MEDIAL TIBIAL COLLAPSE AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. THE PATELLA COMPONENT WAS RETAINED WHILE ALL OTHER COMPONENTS WAS REVISED. DOI: (B)(6) 2016 DOR: (B)(6) 2021 LEFT KNEE.

    Patient problems: Joint Laxity

    MAUDE report 12751968 ↗
  • InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PC WAS CREATED TO CAPTURE THE EVENT DURING REVISION ON (B)(6) 2020. DURING THE REVISION SURGERY, THE PATIENT ALSO SUSTAINED A STROKE EVENT THAT CAUSED IMPAIRED SHORT-TERM MEMORY. DOE: (B)(6) 2020.

    Patient problems: Stroke/CVA

    MAUDE report 12218381 ↗
  • InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    MEDICAL RECORDS RECEIVED INDICATED THAT ON (B)(6) 2014, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY AND ARTHROCENTESIS OF RIGHT KNEE TO ADDRESS DEGENERATIVE JOINT DISEASE OF THE LEFT AND RIGHT KNEE. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT X1, WERE USED DURING THIS PROCEDURE. ON (B)(6) 2019. THE PATIENT REPORTED HAVING INCREASING PAIN. RADIOGRAPHS WERE NOTED TO SHOW VARUS ALIGNMENT OF THE TIBIAL COMPONENT WITH WHAT APPEARS TO BE LUCENCY AROUND THE TIBIAL TRAY AND POSSIBLE SUBSIDENCE. IN (B)(6) 2020, THE PATIENT HAD AN ASPIRATION AND NO GROWTHS WERE NOTED ON (B)(6) 2020, THE PATIENT HAD A LEFT REVISION TO ADDRESS LOOSE LEFT TIBIAL TRAY WITH VARUS KNEE DEFORMITY AND LARGE MEDIAL PROXIMAL TIBIAL DEFECT. DURING THE PROCEDURE, THE SURGEON OBSERVED TIBIAL BONE LOSS, WITH WELL-FIXED FEMORAL AND PATELLAR COMPONENTS AND LAXITY TO VARUS AND VALGUS STRESS. THE TIBIAL TRAY WAS NOTED TO BE LOOSE AT THE IMPLANT/CEMENT INTERFACE. THE FEMORAL COMPONENT WAS REVISED, THE PATELLA REMAINED IN SITU. THE TIBIAL TRAY WAS NOTED TO HAVE MIGRATED LATERALLY. THERE WAS EXTENSIVE BONE LOSS. COMPETITOR COMPONENTS WERE USED DURING THIS PROCEDURE, INCLUDING COMPETITOR CEMENT X4. DOI: (B)(6) 2

    Patient problems: Joint Laxity; Loss of Range of Motion; Nerve Damage; Pain; Swelling/ Edema

    MAUDE report 12217439 ↗
  • InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    (B)(4) MEDICAL RECORDS AD 24 MAY 2021 WERE REVIEWED 06/07/2021. ON (B)(6) 2017, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT X1. ON (B)(6) 2018, THE PATIENT HAD A REMOVAL OF PROSTHESIS, TOTAL KNEE ARTHROPLASTY TO ADDRESS, INFECTION, AND LOOSE TIBIAL COMPONENT. PRIOR TO SURGERY, THE PATIENT WAS NOTED TO HAVE HAD PAIN. DURING THE PROCEDURE, THE SURGEON OBSERVED SIGNIFICANT PURULENCE, SYNOVITIS, AND TIBIAL TRAY LOOSENING AT THE IMPLANT/CEMENT INTERFACE. COMPETITOR COMPONENTS WERE USED DURING THIS PROCEDURE. DOI: (B)(6) 2017 DOR: (B)(6) 2018 (LEFT KNEE).

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

    MAUDE report 11995411 ↗
  • InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2015, THE PATIENT RECEIVED AN ATTUNE LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS. A CEMENTED FIXED BEARING POSTERIOR STABILIZED KNEE WAS IMPLANTED, USING 2 BATCHES OF DEPUY GENTAMYCIN BONE CEMENT. THERE WERE NO REPORTED COMPLICATIONS. THE PATIENT'S LEFT KNEE WAS REVISED TO ADDRESS PAIN, SWELLING, AND ASEPTIC LOOSENING OF THE FEMUR AND THE TIBIAL TRAY IMPLANTS. THE REVISING SURGEON DETERMINED THAT THE FEMUR WAS GROSSLY LOOSE AT THE CEMENT TO BONE INTERFACE, WITH THE PRESENCE OF A LARGE CYST BENEATH THE CEMENT MANTLE. THE TIBIAL TRAY WAS ALSO GROSSLY LOOSE, BUT IN THIS CASE, IT WAS LOOSE AT THE IMPLANT TO CEMENT INTERFACE--THERE WAS NO CEMENT BONDED TO THE BACKSIDE OF THE TIBIAL TRAY IMPLANT. THE CEMENT MANTLE WAS REMOVED FROM THE PROXIMAL BONY TIBIA WITHOUT SIGNIFICANT BONE LOSS. THERE WAS NO EVIDENCE OF EFFUSION OR INFECTION, BUT THERE WAS EXTENSIVE SYNOVITIS REPORTED. THE PATIENT'S PRIMARY PATELLA WAS RETAINED. DURING IMPLANTATION OF THE REVISION FEMUR CONSTRUCT, A NON-DISPLACED FEMORAL FRACTURE WAS IDENTIFIED, WHICH WAS TREATED WITH TWO CERCLAGE CABLES. THE PATIENT WAS PLACED ON LIMITED WEIGHT BEARING PRECAUTIONS FOLLOWING THE REVISION PROCEDURE TO FURTHER AD

    Patient problems: Cyst(s); Pain; Swelling/ Edema; Synovitis

    MAUDE report 11841168 ↗
  • InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT RECEIVED A LEFT PRIMARY ATTUNE TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND AN OF COMPETITOR CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT PAIN, REDUCED ROM, AND WALKING DIFFICULTY SECONDARY TO LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, REDUCED ROM WAS CONFIRMED AND SCAR TISSUE WAS DEBRIDED. THE FEMORAL COMPONENT WAS REVISED WITH SOME BONE LOSS. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED WITH BONE LOSS. THE PATELLA WAS WELL FIXED AND STABLE AND WAS RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATIENT WAS REVISED WITH A COMPETITOR KNEE CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2018 DOR: (B)(6) 2021 LEFT KNEE.

    Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion; Pain

    MAUDE report 11813921 ↗

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